Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts...

74
Qualification Guideline Qualification Guideline for Microsoft Office 365 June 2013

Transcript of Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts...

Page 1: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline Qualification Guideline for Microsoft Office 365

June 2013

Page 2: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 2 of 74

Document MTM-O365-GDE-01 Revision 01

Disclaimer:

This document is meant as a reference to Life Science companies in regards to the Microsoft O365 platform. Montrium does

not warrant that the use of the recommendations contained herein will result in a qualified system or that a system validated

within Office 365 in accordance with this document will be acceptable to regulatory authorities.

This document is provided “as-is.” Information and views expressed in this document, including URL and other Internet Web

site references, may change without notice.

Limitation of Liability:

In no event shall Montrium or any of its affiliates or the officers, directors, employees, members, or agents of each of them, be

liable for any damages of any kind, including without limitation any special, incidental, indirect, or consequential damages,

whether or not advised of the possibility of such damages, and on any theory of liability whatsoever, arising out of or in

connection with the use of this information.

Page 3: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 3 of 74

Document MTM-O365-GDE-01 Revision 01

Authors

Michael Zwetkow VP Operations, Montrium Inc.

Stephanie Tanguay Quality Assurance Manager, Montrium Inc.

Paul Fenton CEO, Montrium Inc.

Gabrielle Soucy Sr. Business Analyst, Montrium Inc.

Page 4: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 4 of 74

Document MTM-O365-GDE-01 Revision 01

Foreword

Over the last few years, Microsoft has paid an increasing amount of attention to a couple of key concepts that are represented in this whitepaper: compliance and the cloud. Together these concepts represent a fairly radical departure from normal business. By enabling cloud technologies, which provide an ease of use and ease of implementation, with compliance, which provides the ability to work with information in a regulatory compliant fashion, the implementing party may find the best of both worlds. This set of guideline whitepapers show how Microsoft is committed to cloud and compliance, spanning Infrastructure as a Service (IaaS), Platform as a Service (PaaS) and Software as a Service (SaaS), a relatively unique combination of technologies and commitment to compliance. At the end of the day these are qualification guidelines and do not represent any guarantees from Microsoft that your processes can be validated in any of the environments discussed or against any of the regulations or standards discussed. Yet when paired with the documentation referred to herein along with customer evidence, these guidelines offer customers a starting point for their own “compliance in the cloud” efforts, a starting point that may be furthered by the expertise Montrium has demonstrated in producing these guidelines. Mohamed Ayad, Cloud Solution Specialist Les Jordan, Chief Technology Strategist Health & Life Sciences Industry Unit Microsoft

Page 5: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 5 of 74

Document MTM-O365-GDE-01 Revision 01

Executive Summary

The purpose of this document is to assist Microsoft’s life science customers in establishing a

qualification strategy for the Microsoft Office 365 (O365) software service. This guideline identifies the

responsibilities shared by Microsoft and its customers for meeting the regulatory requirements of FDA

21 CFR Part 11 Electronic Records; Electronic Signatures (21 CFR Part 11) and EudraLex Volume 4 - Annex

11 Computerised Systems (Annex 11).

The intended audience for this guideline is any regulated customer within the life sciences industry,

aiming to use the O365 platform to run GxP regulated applications. It is assumed that these regulated

applications will support GxP activities and produce and/or manage electronic records.

Traditionally GxP computerized systems have been deployed on specific servers either directly or

through the use of virtual machines. This underlying hardware was usually qualified, managed and

specifically identified as being part of a specific instance of a GxP computerized system. With cloud

computing this paradigm changes slightly. The O365 software solution is composed of many hardware

and software components which all fall under the same controls that have been identified in this

guideline. Each time a new customer instance of O365 is commissioned, it is done using the same

controlled process and standards. When considering public cloud based systems, it is important to view

the whole public cloud as one system upon which we are able to install and run GxP computerized

systems and applications. This guideline will help companies achieve this by providing references to the

21 CFR Part 11 controls that are present within the O365 environment and that should be identified in

customer qualification documentation.

Microsoft’s GFS and O365 platform services have undergone SSAE 16 Service Organization Control (SOC)

audits and are also certified according to ISO/IEC 27001:2005 standards. Although these standards do

not specifically focus on regulatory compliance, their objectives are very similar to those of 21 CFR Part

11 and Annex 11. Montrium has therefore decided to leverage the reports produced by independent

third party SSAE and ISO auditors to identify the procedural and technical controls established at

Microsoft that could be used to satisfy the requirements of 21 CFR Part 11 and Annex 11. It was

assumed that these audit reports were generated by qualified third party auditors and that all

information contained within the reviewed audit reports was objective and accurate at the time of the

audits. It is expected that customers will perform an independent analysis and verification of relevant

regulatory requirements to determine if the GxP applications deployed on O365 are fit for their

intended purpose. The customer must also ensure that GxP applications system will be sufficiently

documented and validated to further demonstrate compliance.

GFS delivers the core infrastructure and foundation technologies for Microsoft's Online Services

environment. Microsoft Office O365 is subscription-based software service hosted by the Global

Foundation Services (GFS) group within Microsoft managed data centers. The services included as part

of O365 are Microsoft SharePoint Online, Microsoft Exchange Online, Microsoft Lync Online and

Microsoft Forefront Online Protection for Exchange. This guideline focuses on the Microsoft SharePoint

Online service, which is the only O365 service which when configured appropriately, provides the ability

Page 6: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 6 of 74

Document MTM-O365-GDE-01 Revision 01

to manage electronic records in manner that could satisfy applicable regulatory requirements. The O365

platform is classified as a public, off-premise, third-party managed solution which is offered via the SaaS

cloud service model. From the perspective of a regulated user (customer), Microsoft Office is considered

to be Category 4 – Configured Product as defined in GAMP5®. O365 is considered to be an “open

system” per 21 CFR Part 11, therefore additional measures, such as encryption should be employed to

further secure information stored within or transiting from the system. It should be noted that only

certain versions of O365 is able to meet the 21 CFR Part 11 requirements for open systems.

Audited controls implemented by Microsoft serve to ensure confidentiality, integrity and availability of

data stored on O365 and correspond to the applicable regulatory requirements defined in 21 CFR Part

11 and Annex 11 that have been identified as the responsibility of Microsoft. Microsoft is responsible for

ensuring that O365 meets the terms defined within the governing Service Level Agreements (SLA).

In addition to ensuring that computerized systems have the relevant technical controls outlined in the

assessment contained within the guideline, the customer is also responsible for ensuring adequate

procedural controls governing the use of the GxP computerized system are in place. These procedural

controls should cover the technical aspects of system management, including but not limited to logical

security, user management, data backup and disaster recovery. There should also be procedural

controls relating to the operation of the GxP computerized system. The customer should determine the

GxP requirements that apply to the computerized system based on its intended use and follow internal

procedures governing qualification and/or validation processes to demonstrate that the GxP

requirements are met.

In conclusion, following the assessment performed by Montrium, it is felt that the audited procedural

and technical controls that Microsoft has implemented could serve to demonstrate that the O365

platform is being maintained in a state of control that is in accordance with the applicable regulatory

requirements. Moreover, the customer may leverage the audited controls described in this document

and related audit reports as part of the risk analysis and qualification effort of their GxP applications

deployed in the O365 environment.

Page 7: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 7 of 74

Document MTM-O365-GDE-01 Revision 01

Table of Contents

Authors .......................................................................................................................................................... 3

Foreword ....................................................................................................................................................... 4

Executive Summary ....................................................................................................................................... 5

Table of Contents .......................................................................................................................................... 7

1 Introduction .......................................................................................................................................... 8

1.1 Purpose ......................................................................................................................................... 8

1.2 Key Definitions .............................................................................................................................. 8

1.3 Audience and Scope ...................................................................................................................... 9

1.4 Methodology ................................................................................................................................. 9

1.5 Glossary ....................................................................................................................................... 11

2 System Overview................................................................................................................................. 14

2.1 Global Foundation Services......................................................................................................... 14

2.2 Microsoft Office 365 ................................................................................................................... 14

2.3 System Classification ................................................................................................................... 15

2.4 Microsoft Audits and Certifications ............................................................................................ 16

2.5 Microsoft Controls ...................................................................................................................... 18

3 Qualification Approach ....................................................................................................................... 23

3.1 Qualification Activities and Responsibilities ............................................................................... 24

3.2 US FDA 21 CFR Part 11 Electronic Records; Electronic Signatures Compliance Assessment ..... 26

3.3 EudraLex Volume 4 Annex 11 Computerised Systems Compliance Assessment ....................... 40

4 Conclusion ........................................................................................................................................... 70

5 References .......................................................................................................................................... 71

6 Appendices .......................................................................................................................................... 72

Appendix A. Recommended Procedures / Policies ............................................................................. 72

Page 8: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 8 of 74

Document MTM-O365-GDE-01 Revision 01

1 Introduction

1.1 Purpose

The purpose of this document is to assist Microsoft’s life science customers in establishing a

qualification strategy for the Microsoft Office 365 (O365) software service, which is hosted on the

infrastructure provided by the Global Foundation Services (GFS) group within Microsoft. The

guidance provided in this document is based on the assumption that Microsoft’s customers will

utilize the O365 service as a GxP application to perform GxP regulated activities.

This guideline identifies the responsibilities shared by Microsoft and its customers for meeting the

regulations specified within Section 1.2. A summary is provided of the procedural and technical

controls which govern the O365 service and can be leveraged by the regulated user (customer) to

demonstrate compliance with applicable regulatory requirements. Also summarized within this

guideline, are recommended activities and controls that should be established by customers in

order qualify and maintain control over the GxP application configured to run on O365.

The qualification approach outlined within this guideline is based on industry best practices with

an emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good

Practice Guides (Ref. [7]) and PIC/S PI 011-3 Good Practices for Computerised Systems in

Regulated ‘GxP’ Environments (Ref. [17]).

1.2 Key Definitions

1.2.1 GxP computerized system

A GxP computerized system is defined as application configured on the O365 platform that will

support activities and records governed by regulations pertaining to GLP, GCP and GMP

environments.

1.2.2 GxP activity

Any regulated activity performed with the context of GLP, GCP and GMP environments.

1.2.3 Customer

Within the context of this guideline, the customer is defined as any person or persons using a

GxP computerized system hosted on the O365 platform, who are responsible for the content of

the electronic records produced and/or managed within the GxP computerized system.

1.2.4 Customer Data on Storage

As per the Microsoft O365 Privacy Statement (Ref. [19]), “Customer Data is all the data,

including all text, sound, software or image files that you provide, or are provided on your

behalf, to us through your use of the Services.” For example, Customer Data on storage includes

data that customers upload for storage or processing in the O365 platform, and applications

that customer or customer’s end users upload for hosting in the Services. Customer Data on

Storage does not include configuration or technical settings and information. Microsoft does not

Page 9: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 9 of 74

Document MTM-O365-GDE-01 Revision 01

monitor or approve the applications that customers configure on O365. Microsoft does not

claim ownership of the Data on Storage. Microsoft’s Online Services Use Rights (Ref. [20]) states

“you [the customer] retain all right, title and interest in and to customer data. We [Microsoft]

acquire no rights in customer data, other than the rights you grant to us for the applicable

online service. This does not apply to software or services we license you.” Data security beyond

the access controls mechanisms, including but not limited to fine-grain access controls or

encryption, is the responsibility of the customer.

1.3 Audience and Scope

The intended audience for this guideline is any regulated customer within the life sciences

industry, aiming to configure the O365 platform for use as a GxP application(s). It is assumed that

the application will support GxP activities and produce and/or manage electronic records. The

specific GxP activities performed within the customer’s O365 environment are not addressed in

this guidance document, as the customer is responsible for defining the requirements and

evaluating the risk associated with each GxP application within the O365 environment.

The regulations within the scope of this qualification guidance document are limited to the

following:

FDA 21 CFR Part 11 Electronic Records; Electronic Signatures - Subpart A and B (Sec 11.10

and Sec 11.30) (Ref. [5])1

EudraLex Volume 4 - Annex 11 Computerised Systems (Ref. [8])2

The O365 platform consists of several services as described in Section 2.2; however, Microsoft

SharePoint Online is the only service which could provide the ability to generate or manage

electronic records within the context GxP regulated activities. Therefore, this guidance will focus

on the functionality of SharePoint Online as it relates to the management of electronic records.

This guideline also covers the underlying infrastructure components provided by the Global

Foundation Services group upon which the O365 service is delivered to Microsoft customers.

1.4 Methodology

Microsoft’s GFS and O365 platform services have undergone SSAE 16 Service Organization Control

(SOC) audits and are also certified according to ISO/IEC 27001:2005 standards (see Section 2.4).

Montrium has leveraged the reports produced by independent third party auditors to identify

procedural and technical controls established at Microsoft which could be used to satisfy

1 21 CFR Part 11 subparts related to electronic signatures are out of scope for this guide, as Microsoft does not

provide electronic signature functionality as part of the above services. 2 Although Eudralex Volume 4 Annex 11 specifically discusses GMP systems, it is generally accepted in industry that

the same principals in the most part are applicable to GCP and GLP systems.

Page 10: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 10 of 74

Document MTM-O365-GDE-01 Revision 01

regulatory requirements within US FDA 21 CFR Part 11 (Ref. [5]) and EudraLex Volume 4 - Annex

11 (Ref. [8]). These controls are described in detail in Section 2.5. Montrium based the analysis on

the ISO and SSAE 16 standards as they have similar objectives to 21 CFR Part 11 and EudraLex

Volume 4 - Annex 11 in relation to controls for computerized systems.

The qualification approach summarizes the activities and responsibilities shared between the

regulated user (customer) and the cloud service provider (Microsoft) to qualify the system against

the relevant regulatory requirements. A detailed assessment (see Section 3.2 and 3.3) was

performed on each regulatory requirement to interpret how compliance could be achieved within

the context of a GxP computerized system configured on the O365 platform. The assessment

described the responsibilities of the customer and Microsoft, as well as the activities,

documentation and controls (technical/procedural) that are required to meet the regulatory

requirement.

The contents of this document are based on these assumptions:

Audit reports listed in Section 2.4 were generated by qualified third party auditors;

All information contained within the reviewed audit reports was objective and accurate at

the time of the audits;

Customers will perform an independent analysis and verification of related regulatory

requirements to determine if the O365 platform is fit for its intended purpose;

The O356 application(s) will be sufficiently documented and validated by the customer to

demonstrate compliance with all applicable regulations;

The customer will use only out-of-the-box functionality and will not be installing

developing any customizations or 3rd party applications within the O365 environment.

Page 11: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 11 of 74

Document MTM-O365-GDE-01 Revision 01

1.5 Glossary

Term Definition

AICPA American Institute of Certified Public Accountants

CFR Code of Federal Regulations

Closed System An environment in which system access is controlled by persons who are

responsible for the content of electronic records that are on the system.3

Cloud

Infrastructure as a

Service (IaaS).

The capability provided to the consumer is to provision processing, storage,

networks, and other fundamental computing resources where the consumer is

able to deploy and run arbitrary software, which can include operating systems

and applications. The consumer does not manage or control the underlying cloud

infrastructure but has control over operating systems, storage, deployed

applications, and possibly limited control of select networking components (e.g.,

host firewalls).4

Cloud Platform as

a Service (PaaS)

The capability provided to the consumer is to deploy onto the cloud infrastructure

consumer-created or acquired applications created using programming languages

and tools supported by the provider. The consumer does not manage or control

the underlying cloud infrastructure including network, servers, operating systems,

or storage, but has control over the deployed applications and possibly application

hosting environment configurations.4

Cloud Software as

a Service (SaaS) The capability provided to the consumer is to use the provider’s applications

running on a cloud infrastructure. The applications are accessible from various

client devices through a thin client interface such as a Web browser (e.g., Web-

based email). The consumer does not manage or control the underlying cloud

infrastructure including network, servers, operating systems, storage, or even

individual application capabilities, with the possible exception of limited user

specific application configuration settings.

Computerized

System

Includes hardware, software, peripheral devices, personnel, and documentation;

e.g., manuals and Standard Operating Procedures.5

Customer O365 user using the software service for GxP regulated activities.

CV Curriculum Vitae

3 FDA 21 CFR Part 11 (Ref. [4]).

4 NIST Cloud Computing Standards Roadmap (Ref. [9])

5 FDA, Glossary of Computer Systems Software Development Terminology (8/95)

Page 12: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 12 of 74

Document MTM-O365-GDE-01 Revision 01

Term Definition

Electronic Record Any combination of text, graphics, data, audio, pictorial, or other information

representation in digital form that is created, modified, maintained, archived,

retrieved, or distributed by a computer system.3

FDA United States Food and Drug Administration

GAMP Good Automated Manufacturing Practice

GFS Global Foundation Services

GCP Good Clinical Practice

GLP Good Laboratory Practice

GMP Good Manufacturing Practice

GxP Compliance requirements for all good practice disciplines in the regulated

pharmaceutical sector supply chain from discovery to post marketing.6

IaaS Infrastructure as a Service

ID Identifier

IEC International Electrotechnical Commission

ISO International Organization for Standardization

ISPE International Society of Pharmaceutical Engineers

IT Information Technology

NDA Non-Disclosure Agreement

NIST National Institute of Standards and Technology

Open System An environment in which system access is not controlled by persons who are

responsible for the content of electronic records that are on the system.3

O/S Operating System

PaaS Platform as a Service

PIC/S Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-

operation Scheme

Procedure The term “procedure” within the context of this document refers to any approved

and effective controlled document governing specific processes (i.e. Policy, SOP,

Standard, Guide, Work Instruction).

6 PIC/S (Ref. [17])

Page 13: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 13 of 74

Document MTM-O365-GDE-01 Revision 01

Term Definition

SaaS Software as a Service

SDLC Software Development Lifecycle

SLA Service Level Agreement

SMAPI System Management Application Program Interface

SOC Service Organization Controls

SOP Standard Operating Procedure

SSAE Statement on Standards for Attestation Engagements

SSL Secure Sockets Layer

STB Microsoft Server and Tools Business

TLS Transport Layer Security

TSP Trust Services Principles

VM Virtual Machine

VPN Virtual Private Network

Page 14: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 14 of 74

Document MTM-O365-GDE-01 Revision 01

2 System Overview

2.1 Global Foundation Services

Global Foundation Services (GFS) delivers the core infrastructure, foundation technologies and

operational support for Microsoft's Online Services environment, including O365. As described

within the GFS SOC 2 report (Ref. [2]), the GFS operational infrastructure services include the

following:

Engineering and operations for core infrastructure (networking, directory services, access

services, data retention and backup, hardware and software procurement, physical and

environmental controls)

Deployment, hosting and data center services

Service support, monitoring and escalation

Information security management and compliance monitoring

2.2 Microsoft Office 365

Microsoft Office O365 is subscription-based software service hosted by the Global Foundation

Services group within Microsoft managed data centers. As described within the O365 SOC 1

report (Ref. [1]), the O365 hosted service is offered in two ways:

Microsoft Office 365 – where all customers receive a standard set of features they

subscribe to, hosted on a multi-tenant basis

Microsoft Office 365 Dedicated (O365-D) – hosts applications and services with a separate,

secured hardware infrastructure dedicated to a single customer

The services included as part of O365 and O365-D are: Microsoft SharePoint Online, Microsoft

Exchange Online, Microsoft Lync Online and Microsoft Forefront Online Protection for Exchange.

This guideline will focus on the Microsoft SharePoint Online service, which is the only O365

service which when configured appropriately, provides the ability to manage electronic records in

manner that could satisfy applicable regulatory requirements (see Section 1.3). SharePoint Online

allows users to create and store data as well as documents in lists and libraries within SharePoint

which can be configured with audit trails and versioning. In addition, user permissions can be

configured to control access to the content stored with the various lists and libraries.

Page 15: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 15 of 74

Document MTM-O365-GDE-01 Revision 01

In order to be able to meet regulatory requirements for encryption, the software service must

also provide the ability to encrypt data which is stored within the application. The Active Directory

Rights Management functionality can be configured to encrypt documents stored with

SharePoint. However, this functionality is only available with the SharePoint Online Plan 2 option,

which is included in the following O365 plans:

Office 365 Enterprise E3

Office 365 Education A3

Office 365 Government G3

Office 365 Enterprise E4

Office 365 Education A4

Office 365 Government G4

2.3 System Classification

2.3.1 Cloud Service Model

The O365 platform is classified as a public, off-premise, third-party managed solution which is

offered via the SaaS cloud service model (see NIST definition in Section 1.5). The following

diagram depicts the various components of the software service which are managed by

Microsoft as part of the SaaS service model.

Figure 1 – SaaS Cloud Service Model (based on Ref. [18])

Page 16: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 16 of 74

Document MTM-O365-GDE-01 Revision 01

2.3.2 GAMP5® Category

From the perspective of a regulated user (customer), Microsoft Office is considered to be

Category 4 – Configured Product as defined in GAMP5® (Ref. [6]). A configured product refers to

a commercially available software product which is configured to meet a specific business

requirement.

2.3.3 FDA Classification

While Microsoft is not directly responsible for the electronic records contained within the O365

platform, it is responsible for maintaining the O365 platform. In addition, Microsoft configures

the O365 platform and establishes access control requirements for logical and physical security.

The O365 platform is therefore considered to be “open” (refer to definition in Section 1.5). The

FDA requires open systems to meet additional requirements, such as encryption, as defined in

21 CFR Part 11.30 (Ref. [5]).

2.4 Microsoft Audits and Certifications

The following table lists the formal audit reports prepared by third parties which were reviewed

by Montrium in order to identify relevant controls which have a potential impact on compliance

with the 21 CFR Part 11 (Ref. [5]) and Annex 11 (Ref. [8]) regulations. Existing Microsoft customers

may request access to these reports subject to NDA terms and conditions, through their

respective Microsoft account representatives.

Audited Service Audit Type Date Reference No.

GFS SOC 2 Type II April 18, 2012 Ref. [2]

Office 365 SOC 1 Type II June 14, 2012 Ref. [1]

Office 365 ISO/IEC 27001:2005 November 16, 2012 Ref. [3]

2.4.1 ISO/IEC 27001:2005 Certification

ISO/IEC 27001:2005 specifies the requirements for establishing, implementing, operating,

monitoring, reviewing, maintaining and improving a documented information security

management system within the context of the organization's overall business risks. It specifies

requirements for the implementation of security controls customized to the needs of individual

organizations or parts thereof.

ISO/IEC 27001:2005 certifications for O365 and Global Foundation Services can be found by

clicking on the following links:

Microsoft Office 365 ISO/IEC 27001:2005 certificate

GFS ISO/IEC 27001:2005 certificate

Page 17: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 17 of 74

Document MTM-O365-GDE-01 Revision 01

2.4.2 SOC Service Audit Reports

Service Organization Controls reports are designed by the American Institute of Certified Public

Accountants (AICPA) to help service organizations that operate information systems and provide

information system services to other entities, build trust and confidence in their service delivery

processes and controls through a report by an independent Certified Public Accountant.

SOC 1 Service Audit Reports are conducted in accordance with the professional standard known

as Statement on Standards for Attestation Engagements (SSAE) No. 16. SOC 1 reports are geared

towards reporting on controls at service organizations that are relevant to Internal Control over

Financial Reporting, and replace the SAS 70 auditing standard.

The O365 services group has been audited by independent third party auditors to generate a

SOC 1 Service Auditor’s report which examined the following control areas:

Logical Access

Change Management

Backup and Restoration

Monitoring and Incident Management

Software Development Lifecycle (SDLC)

Network Services

SOC 2 Service Auditor’s Reports are also conducted in accordance with the professional

standard of SSAE 16. SOC2 reports are intended to meet the needs of a broad range of users

that need to understand internal control at a service organization as it relates to security,

availability, processing integrity, confidentiality and privacy and are intended for use by

stakeholders (e.g., customers, regulators, business partners, suppliers, directors) of the service

organization that have a thorough understanding of the service organization and its internal

controls.

The SOC 2 framework is a comprehensive set of criteria known as the Trust Services Principles

(TSP) which are composed of the following five (5) sections:

The security of a service organization' system

The availability of a service organization's system

The processing integrity of a service organization's system

The confidentiality of the information that the service organization's system processes

or maintains for user entities

The privacy of personal information that the service organization collects, uses, retains,

discloses, and disposes of for user entities

The GFS services group has undergone a SOC 2 audit, to examine the suitability of the design

and operating effectiveness of controls to meet the criteria for the security principle set forth in

TSP section 100, Trust Services Principles and Criteria for Security, Availability, Processing

Integrity, Confidentiality, and Privacy (Ref. [11]).

Page 18: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 18 of 74

Document MTM-O365-GDE-01 Revision 01

2.5 Microsoft Controls

This section describes the audited controls implemented by Microsoft which serve to assure

confidentiality, integrity and availability of data stored on the O365 platform. These controls are

also referenced within the compliance assessment sections (see Section 3.2 and 3.3), where they

respond to applicable regulatory requirements.

2.5.1 Security Policies and Procedures

Microsoft has implemented a Security Policy which applies to Microsoft O365. The Security

Organization control objective within the SOC 1 audit reported that the information security

policies are implemented and communicated to the applicable employees.

The GFS SOC 2 audit reported that the security policies are established, periodically reviewed

and approved by a designated individual or group.

The O365 ISO/IEC 27001:2005 audit reported that an approved information security policy has

been published and communicated to all employees and relevant external parties.

2.5.2 Physical and Environmental Security

The physical assets on which the O365 system resides Microsoft has been audited to verify that

proper physical security controls are established to protect the physical assets forming the

foundation of the O365 platform as part of the GFS SOC 2 audit report.

The GFS SOC 2 audit reported that the GFS services group has implemented procedures to

restrict physical access to the infrastructure elements including, but not limited to:

Facilities

Backup media

Firewalls

Routers

Servers

The GFS ISO/IEC 27001:2005 audit reported that procedural controls are in place for tracking

and monitoring physical infrastructures and services, as well as a documented methodology for

determining the asset security level.

2.5.3 Logical Security

The O365 SOC 1 audit reported that Microsoft has implemented logical security controls to

provide reasonable assurance that logical access to the O365 production infrastructure and

systems is restricted to authorized personnel. User Account Management is performed using

Active Directory which centralizes the authentication and authorization to the O365

environment. Policies and standards have been implemented to enforce appropriate user

account password expiration, length, complexity and history.

Page 19: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 19 of 74

Document MTM-O365-GDE-01 Revision 01

The GFS SOC2 audit reported that the GFS services group has implemented procedures to

restrict logical access to the system including, but not limited to, the following measures:

a. Logical access security measures to restrict access to information resources not deemed

to be public

b. Identification and authentication of users

c. Registration and authorization of new users

d. The process to make changes and updates to user profiles

e. Distribution of output restricted to authorized users

f. Restriction of access to offline storage, backup data, systems and media

g. Restriction of access to system configurations, super-user functionality, master

passwords, power utilities and security devices (for example, firewalls)

The O365 ISO/IEC 27001:2005 audit reported that the logical access to the system is restricted

to authorized personnel in accordance with an enforced access control policy.

2.5.4 System Monitoring and Maintenance

The O365 SOC 1 audit reported that proper controls are established to provide reasonable

assurance that the O365 platform is monitored to detect and remediate any security

vulnerabilities.

The following activities/controls were audited in relation to system monitoring and

maintenance:

Vulnerability and Patch Management

Security Incident Management

The GFS SOC 2 audit reported that proper controls are established to monitor the GFS

infrastructure components and proper actions are taken to maintain compliance within its

defined system security policies. Automated tools are used to monitor the security controls on a

regular basis. The GFS group monitors, logs, reports and takes appropriate action to resolve

events involving critical/suspicious activities.

2.5.5 Data Backup, Recovery and Retention

The O365 SOC 1 audit reported that O365 utilizes secure backup system infrastructure delivered

by the Global Foundation Services Data Protection Services.

The GFS SOC 2 audit reported that the GFS Data Protection Services group provides secure

backup retention and restoration of data in the Microsoft Online Services environment. The

audit also reported that the recovery and backup process is tested on an annual basis

2.5.6 Confidentiality

The following excerpt for the publicly available Office 365 Standard Response to Request for

Information - Security and Privacy (Ref. [13]) describes the technical controls which help to

ensure confidentiality of data as it transmits between the customer and the O365 platform:

Page 20: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 20 of 74

Document MTM-O365-GDE-01 Revision 01

“Customer access to services provided over the Internet originates from users’ Internet-enabled

locations and ends at a Microsoft data center. These connections established between

customers and Microsoft data centers are encrypted using industry-standard Transport Layer

Security (TLS) /Secure Sockets Layer (SSL). The use of TLS/SSL effectively establishes a highly

secure browser-to-server connection to help provide data confidentiality and integrity between

the desktop and the data center. Filtering routers at the edge of the Office 365 services network

provides security at the packet level for preventing unauthorized connections to Office 365

Services.”

The GFS SOC 2 audit reported that encryption or other equivalent security techniques are used

to protect user authentication information and the corresponding session transmitted over the

internet or other public networks.

2.5.7 Software Development / Change Management

The O365 SOC 1 audit reported that a formal SDLC process is defined which governs the

development of new features or major changes to the O365 platform with the goal of

minimizing processing errors and security vulnerabilities within the environment. The SDLC

process encompasses the following phases:

Requirements gathering

Design

Implementation

Verification

Release

Key stakeholders are required to provide approval of the tested code prior to deployment of

newly developed or changed code into the production environment.

The O365 SOC 1 audit also reported that a formal change control process has been established

to provide reasonable assurance that changes to the production environment are made in a

controlled manner. Ticketing systems are used to track changes which contain documented

details including appropriate authorizations and approvals.

The GFS SOC 2 audit of the GFS services verified adequate IT change management controls are

established surrounding the following topics:

Service Infrastructure and Support Systems Change Management

Secure Configuration – Imaging

Network Change Management

Network Patch Management

The O365 ISO/IEC 27001:2005 audit reported that a procedural document covering change

management is in place which covers security impact analysis, change control and component

inventory management.

Page 21: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 21 of 74

Document MTM-O365-GDE-01 Revision 01

2.5.8 Incident Management

The O365 SOC 1 audit reported that adequate processes are established governing how

incidents within the production environment are documented and resolved in a timely manner.

The processes are part of an incident management framework that includes defined process

roles, responsibilities, and communications for managing the detection, escalation and response

to incidents.

The GFS SOC 2 audit reported that procedures exist to identify, report, and act upon system

security breaches and other incidents. The Security Incident Management team ensures the

Security Response procedures are tested annually.

The O365 ISO/IEC 27001:2005 audit reported that mechanisms are in place for logging and

monitoring security incidents in O365. Any security events are reported in a timely manner

through the appropriate management channels.

2.5.9 Service Level Agreements

Microsoft provides Service Level Agreements (SLA) related to the O365 and O365-D Dedicated

application service, which are available for download from the Microsoft website.

2.5.10 Risk Assessment

The O365 SOC 1 audit reported that as part of the SDLC process Microsoft has implemented a

comprehensive threat modeling process to identify potential security and privacy issues.

Detailed risk assessments covering both security and privacy are performed with the objective

of remediating any issues detected.

The GFS SOC 2 audit reported that risk assessments are performed within the context of

network device change management to evaluate potential risks associated with the change.

2.5.11 Documentation / Asset Management

The procedure governing software development was audited against a control objective which

stipulates that the development of new features or major changes must be documented. In

addition, Microsoft has confirmed to Montrium that a Document and Records Management

procedure governing protection and retention of documentation is in force. Microsoft has also

indicated to Montrium that the baseline configuration of O365 components is documented,

managed, maintained and controlled for access via access control mechanisms. Additionally, this

configuration is performed according to the Asset management guidelines.

2.5.12 Training Management

The O365 SOC 1 audit reported that all Microsoft employees receive mandatory training on

Microsoft Standards of Business conduct on an annual basis. Microsoft O365 staff and

contingent staff are accountable for understanding and adhering with the Microsoft Online

Services Security Policy.

Page 22: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 22 of 74

Document MTM-O365-GDE-01 Revision 01

The GFS SOC 2 audit reported security policies concerning information security and business

conduct were implemented. Training is mandatory for all employees on these policies.

Procedures and standards cover policy training and training requirements. Training is

documented and compliance with training requirements is monitored.

The O365 ISO/IEC 27001:2005 audit reported that Microsoft has a formal security and

awareness training program which includes security responsibilities, asset ownership, and

classification.

2.5.13 Disaster Recovery

The GFS SOC 2 audit reported processes for backing-up critical components and data, customer

data and credentials are defined and tested on an annual basis. Backup frequency and retention

period is based on the type of data. Data centers used for backup are in a different geographical

location than the primary data center.

The O365 ISO/IEC 27001:2005 audit reported that Microsoft has a formal business continuity

process that describes the information security requirements.

2.5.14 Vendor Management

The O365 SOC 1 audit reported that third party vendors have specific statements of work with

service level agreements that are monitored for compliance and adherence. The Microsoft

Online Services Delivery Platform group works with vendor companies to perform background

checks on individuals before they are granted access to the production environment.

Page 23: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 23 of 74

Document MTM-O365-GDE-01 Revision 01

3 Qualification Approach

Qualification is defined as “a process of demonstrating the ability of an entity to fulfill specified

requirements. In the context of an IT Infrastructure, this means demonstrating the ability of components

such as servers, clients, and peripherals to fulfill the specified requirements for the various platforms

regardless of whether they are specific or of a generic nature.”7 According to industry best practices as

proposed within the GAMP Good Practice Guide: IT Infrastructure Control and Compliance7, in order for

an IT infrastructure platform to be considered qualified and compliant, the following critical aspects

need to be considered:

Installation and operational qualification of infrastructure components

Configuration management and change control of infrastructure components

Management of risks to IT Infrastructure

Involvement of service providers in critical infrastructure processes

Security management in relation to access controls, availability of services and data integrity

Data Backup, Restore, Disaster Recovery, Archiving

In the context of a public SaaS cloud service model, the customer does not have control over the

underlying infrastructure hardware and software components, nor to the application itself. The cloud

service provider is responsible for managing and maintaining these components and ensuring that they

meet the terms defined within the governing Service Level Agreement(s). Microsoft has implemented

controls (see Section 2.5) which encompass these critical aspects of IT infrastructure compliance.

Figure 2 – Qualification of Infrastructure vs. Validation of Applications

Validation consists of demonstrating, with objective evidence, that a system meets the requirements of

the users and their processes and is compliant with applicable GxP regulations. In order to remain in a

validated state, appropriate operational controls must be implemented throughout the life of the

system. As such, validation is performed by the regulated users (customer) of the GxP computerized

7 ISPE, GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Ref. [7])

Applications

Infrastructure Software & Tools

Network Components

Infrastructure Hardware

Data Center Facilities

Validation

Qualification

Page 24: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 24 of 74

Document MTM-O365-GDE-01 Revision 01

systems that reside on the O365 platform. The following diagram depicts the typical deliverables and

activities required in order the implement and validate a system and maintain its validated state during

operation.

Figure 3 – Typical Validation Activities/Deliverables

Additional information for GxP computerized system validation can be found within the following

guidance documents:

PIC / S - Good Practices for Computerised Systems in Regulated “GxP” Environments (Ref. [17])

GAMP 5 - A Risk-Based Approach to Compliant GxP computerized systems (Ref. [6])

3.1 Qualification Activities and Responsibilities

By utilizing the O365 platform, the customer is effectively outsourcing the management and

operations of their IT infrastructure and of the application development to Microsoft. However, it

is important to note that, “the regulated company remains responsible for the regulatory

compliance of their IT operations regardless of whether they choose to outsource/offshore some

or all of their IT Infrastructure processes to external service provider(s). Compliance oversight and

approvals cannot be delegated to the outsource partner.”8

8 ISPE, GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Ref. [7])

• Validation Plan and Reporting

• User Requirement and Acceptance Testing

• Installation Qualification Implementation

• Incident Management

• Operational Change Control

• Periodic Review Operation

Page 25: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 25 of 74

Document MTM-O365-GDE-01 Revision 01

A summary of the Customer’s and Microsoft’s responsibilities, as they relate to the qualification

and validation activities is provided below. A detailed description of each party’s responsibilities,

as they relate to the applicable regulatory requirements, is provided in Section 3.2 (21 CFR Part

11) and Section 3.3 (Annex 11).

3.1.1 Summary of Microsoft Responsibilities

Microsoft is responsible for ensuring that O365 meets the terms defined within the governing

Service Level Agreements (see Section 2.5.9). When new customer environments are deployed

within the O365 platform, they are created using the default configuration established by

Microsoft. Microsoft is responsible for ensuring the system is capable of meeting the

specifications and the terms of the SLA(s).

The O365 platform must be managed in a controlled and secured manner, so as to provide the

following key elements in relation to customer data:

Confidentiality - ensuring that information is accessible only to those authorized to have

access

Integrity - safeguarding the accuracy and completeness of information and processing

methods

Availability - ensuring that authorized users have access to information and associated

assets when required

The controls identified in Section 2.5 are implemented, managed and maintained by Microsoft

to ensure that the above key requirements can be met.

3.1.2 Summary of Customer Responsibilities

The customer is responsible for performing the following activities for each GxP computerized

system requiring qualification and validation within the O365 platform:

1) Develop or identify procedural controls governing the use of the GxP computerized

system. These procedural controls should cover the topics as described in Appendix A,

as well as any other controlled processes which are impacted by the GxP computerized

system including the following:

a. Use of Live IDs and passwords

b. Account access to the O365 platform

c. Compliance management with applicable laws and regulations

d. Customer data encryption requirements

e. O365 SMAPI access certificates acquisition

f. Data access mechanism (public or signed access) for data contained with the O365 platform

g. SharePoint environment configuration

h. Data backup upon O365 subscription termination

Page 26: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 26 of 74

Document MTM-O365-GDE-01 Revision 01

i. Protection of account-related secrecy

j. Security Development Lifecycle for applications developed on O365

k. Quality assurance of applications before moving to O365 Production

l. Security monitoring for applications developed on O365

m. Public O365 security and patch updates review

n. Patch application when not subscribed to auto-upgrade

o. Incident and alert reporting to Microsoft when those are specific to customer systems and O365

p. Incident response support with the O365 team

2) Determine the GxP requirements that apply to the O365 based on its intended use.

3) Follow internal procedures governing Qualification and/or Validation processes,

expected deliverables would include but are not limited to:

a. Qualification / Validation plan describing the activities, responsibilities and

deliverables to be produced for GxP computerized system configured on the

O365 platform

b. Specification documentation describing the GxP computerized system’s

requirements, functionality and intended use

c. Risk Assessments covering both the decision to configure the GxP computerized

system within the O365 platform, and a functional risk assessment of the GxP

computerized system. The assessments should include mitigation actions

required to address identified risks

d. Verification documentation providing evidence that the GxP computerized

system meets its intended use as defined within relevant specification

documents

4) Maintain and operate the GxP computerized system in a secure and controlled manner

according to internally developed procedures as defined in point 1) above.

3.2 US FDA 21 CFR Part 11 Electronic Records; Electronic Signatures Compliance Assessment

The following table outlines the assessment that was performed on each regulatory requirement

of US FDA 21 CFR Part 11 which were identified as in scope in Section 1.2 of this document. The

primary objective of the assessment is to identify the procedural and technical controls that are

required to satisfy the different regulatory requirements.

In conjunction with the responsibilities identified in Section 3.1, we further identify which controls

fall within the responsibility of Microsoft versus the controls that are considered the responsibility

of the customer when using the O365 platform for regulated GxP computerized systems.

Page 27: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 27 of 74

Document MTM-O365-GDE-01 Revision 01

Sec. 11.10 Controls for closed syste ms. 11.10 (a)

SEC. 11.10 CONTROLS FOR CLOSED SYSTEMS. Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following:

11.10 (a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

Customer – Regulated User

The customer is responsible for ensuring any GxP computerized system used to produce and/or manage

electronic records is validated according to an approved and effective procedure. This procedure should

ensure that the validation verifies accuracy, reliability, consistent intended performance, and the ability to

discern invalid or altered records. Additional details regarding the qualification / validation activities are

provided in Section 3.1.2.

Description of activities, documentation and controls:

Perform computer system validation activities for GxP computerized systems as defined within the governing the computer system validation procedure to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records;

Document the qualification/validation activities performed prior to and during the configuration of the GxP computerized systems configured on the O365 platform;

Establish appropriate system performance monitoring to ensure consistent availability and performance of GxP computerized system.

Microsoft – Cloud service provider

Microsoft is not responsible for validation of the GxP computerized systems configured within the O365 platform. Microsoft is responsible for ensuring the O365 platform performs consistently and reliably by implementing adequate controls over the development, deployment and testing of the software applications which make up the O365 platform.

Microsoft meets these requirements through the following controls:

System Monitoring and Maintenance (see Section 2.5.4)

Software Development / Change Management (see Section 2.5.7)

Page 28: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 28 of 74

Document MTM-O365-GDE-01 Revision 01

11.10 (b)

11.10 (b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records.

Customer – Regulated User

The customer is responsible for implementing adequate controls to secure the GxP computerized systems

which contain electronic records and provide appropriate system monitoring. These controls should

ensure that the electronic records which are stored within the GxP computerized systems configured on

the O365 platform are protected to prevent corruption or loss of information. The customer is also

responsible for ensuring that GxP computerized systems configured on the O365 platform are capable of

generating accurate and complete copies of records in both human readable and electronic form suitable

for inspection, review, and copying by the agency.

Description of activities, documentation and controls:

Establish Procedure(s) to govern the protection of records to ensure accurate and complete copies are readily available including:

o Documentation Management – to define who is responsible for managing documentation within the organization;

o Records Retention and Archiving – to ensure adequate record retention policies and archive management processes are in place;

o Backup and Restoration – to ensure proper protection of records through backup mechanisms with regular restoration tests;

o Disaster recovery – to ensure that electronic records can be retrieved properly in the event of a disaster and that this retrieval is tested periodically;

o System Monitoring – to ensure consistent availability and performance of GxP computerized system;

Verify accurate and complete copies of electronic records can be retrieved from the GxP computerized systems configured on the O365 platform;

Verify that data transfer from GxP computerized systems which store electronic records on the O365 platform does not impact data integrity;

Ensure that record retention procedures establish long term archiving controls so that electronic records can be retrieved throughout the required retention period from the O365 platform (or until they are moved to another long term archiving environment outside of the O365 platform);

Page 29: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 29 of 74

Document MTM-O365-GDE-01 Revision 01

11.10 (b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records.

Microsoft – Cloud service provider

Microsoft is responsible for implementing adequate controls to secure the O365 platform and provide

appropriate system monitoring. By securing and monitoring the O365 platform, these controls help to

satisfy the above regulatory requirement, such that the GxP computerized systems are protected and are

continually available.

Microsoft meets these requirements through the following controls:

Security Policies and Procedures (see Section 2.5.1)

Physical Security (see Section 2.5.2)

Logical Security (see Section 2.5.3)

System Monitoring and Maintenance (see Section 2.5.4)

Page 30: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 30 of 74

Document MTM-O365-GDE-01 Revision 01

11.10 (c)

11.10 (c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.

Customer – Regulated User

The customer is responsible for ensuring that appropriate controls are established to protect records

pertaining to GxP activities performed within GxP computerized systems which are configured on the O365

platform and to ensure the records are readily available throughout their retention period.

O365 SharePoint Online provides the ability to declare content as records and, through configuration,

apply the necessary controls such as audit trail, security and record retention policies to meet the technical

requirements of 21 CFR Part 11 and other relevant regulations (see section 2.2. for more information).

Description of activities, documentation and controls:

Establish procedure(s) that govern the following topics:

o Logical security - describing the security controls which are required in order to prevent unauthorized access to the application;

o Records Retention and Archiving – to ensure adequate record retention policies and archive management processes are in place

o Backup and Restoration – to ensure proper protection of records through backup mechanisms with regular restoration tests;

o System Monitoring – to ensure consistent availability and performance of GxP computerized system;

Data repatriation plans are established and tested in the case of contract termination with Microsoft for Office 365 services;

Verify that the O365 SharePoint Online records management functionality is properly configured to meet 21 CFR Part 11 and other applicable regulatory record retention requirements.

Microsoft – Cloud service provider

Microsoft is responsible for implementing adequate controls to secure the O365 platform, provide

appropriate system backup and data retention policies. Data backup and retention policies/procedures are

defined and maintained in accordance to regulatory, statutory, contractual or business requirements.

These controls help to satisfy the above regulatory requirement, such that Microsoft backs up O365

infrastructure data regularly and validates restoration of data periodically for disaster recovery purposes.

Microsoft meets these requirements through the following controls:

Security Policies and Procedures (see Section 2.5.1)

Physical Security (see Section 2.5.2)

Logical Security (see Section 2.5.3)

System Monitoring and Maintenance (see Section 2.5.4)

Data Backup, Recovery and Retention (see Section 2.5.5)

Page 31: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 31 of 74

Document MTM-O365-GDE-01 Revision 01

11.10 (d)

11.10 (d) Limiting system access to authorized individuals.

Customer – Regulated User

The customer is responsible for ensuring that an individual must have a valid user account in order to

access both the O365 platform and any relevant GxP computerized system. Within the O365 platform,

user permissions must be managed by the System Administrator to specify what areas of the

computerized system are accessible to authorized users.

Description of activities, documentation and controls:

O365 customers must register for the service by creating a subscription through the O365 Portal web site;

Ensure proper user management procedures are in place to govern access to the O365 environment;

Ensure proper procedures are established to govern logical and physical security over the terminal devices (e.g. workstations, laptops, etc.) used to access the O365 platform. The procedure should clearly describe how access to the system is managed, as well as how user system access is documented;

Appropriate System Administration practices are followed for GxP computerized systems configured on the O365 platform based on predefined system administration procedures.

Microsoft – Cloud service provider

Microsoft is responsible for ensuring adequate controls are established to ensure access to the O365

platform is restricted to authorized individuals.

Microsoft meets these requirements through the following controls:

Security Policies and Procedures (see Section 2.5.1)

Physical Security (see Section 2.5.2)

Logical Security (see Section 2.5.3)

Page 32: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 32 of 74

Document MTM-O365-GDE-01 Revision 01

11.10 (e)

11.10 (e) Use of secure, computer-generated time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.

Customer – Regulated User

The O365 environment provides a standard audit trail feature. This feature must be turned on and

configured as part of the installation process for GxP computerized system configured on the O365

platform (see section 2.2. for more information).

Description of activities, documentation and controls:

Verify that audit trails are being properly generated for electronic records within O365 based on the requirements of 21 CFR Part 11.10 (e);

Verify that audit trail entries can be retrieved and that audit trail entries remain linked to their respective records throughout their retention period;

Verify that the audit trail can be retrieved as a human readable record;

Ensure Procedure(s) are established governing the following activities:

o Record retention and archiving - should define how audit trails will be protected throughout their corresponding records lifetime;

o Logical security – to ensure adequate protection and integrity of audit trails as electronic records in their own right;

o System Administration procedures for the GxP computerized systems configured on the O365 platform to ensure the proper management of audit trails;

o System Monitoring – to ensure consistent availability and performance of GxP computerized system.

Microsoft – Cloud service provider

Customers are responsible for ensuring that the audit trail functionality provided in the O365 platform is

properly configured. Microsoft is responsible for implementing adequate controls to secure the O365

platform and provide appropriate system monitoring. By securing and monitoring the O365 platform,

these controls help to satisfy the above regulatory requirement, such that the GxP computerized systems

are protected and are continually available.

Microsoft meets these requirements through the following controls:

Security Policies and Procedures (see Section 2.5.1)

Physical Security (see Section 2.5.2)

Logical Security (see Section 2.5.3)

System Monitoring and Maintenance (see Section 2.5.4)

Data Backup, Recovery and Retention (see Section 2.5.5)

Page 33: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 33 of 74

Document MTM-O365-GDE-01 Revision 01

11.10 (f)

11.10 (f)

Use of operational system checks to enforce permitted sequencing of steps and events as appropriate.

Customer – Regulated User

Operational checks are typically present in the process control mechanisms of GxP computerized systems

to ensure that operations are not executed outside of the predefined order established by the operating

group.

The customer should ensure that GxP computerized system configured on the O365 platform have been

assessed and are capable of fulfilling this requirement.

Microsoft – Cloud service provider

Within the context of the O365 platform, Microsoft provides certain operational system checks such as

authentication mechanisms, however all operational checks should be verified with the GxP computerized

system managed by the customer.

Page 34: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 34 of 74

Document MTM-O365-GDE-01 Revision 01

11.10 (g)

11.10 (g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand

Customer – Regulated User

The customer is responsible for ensuring that adequate authority checks are implemented where

necessary through the application of security policies and the centralized management of user permissions

within the GxP computerized system. The customer is responsible for managing the access mechanism to

GxP computerized systems configured on the O365 platform (see Section 3.1.2).

Description of activities, documentation and controls:

Establish a procedure describing the process for managing user accounts and user permissions for the GxP computerized system;

The verification that only authorized users are able to access and alter records contained within the GxP computerized system should be performed as part of the validation effort.

Microsoft – Cloud service provider

The customer is primarily responsible for implementing and verifying the proper application of authority

checks in order to fulfill this regulatory requirement. Microsoft maintains the system which authenticates

users of the GxP computerized system, and must also manage authentication and security for the O365

platform. Microsoft is therefore responsible for ensuring proper controls are established to securely

manage the user access control system.

Microsoft meets these requirements through the following controls:

Security Policies and Procedures (see Section 2.5.1)

Physical Security (see Section 2.5.2)

Logical Security (see Section 2.5.3)

Page 35: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 35 of 74

Document MTM-O365-GDE-01 Revision 01

11.10 (h)

11.10 (h)

Use of device (e.g. terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.

Customer – Regulated User

The customer must determine whether the implementation of device checks is required based on the

intended use of the GxP computerized system and the associated risks. Device checks are warranted in an

environment where only certain devices have been selected as legitimate sources of data input or

commands. In such cases, the device checks would be used to determine if the data or command source

was authorized. If required, the customer is responsible for defining which devices are authorized to

provide data or operational instructions and implement the necessary controls within the GxP

computerized system configured on the O365 platform.

Microsoft – Cloud service provider

Within the context of the O365 cloud services, Microsoft does not have control over device checks, as

these would be implemented and managed by the customer.

11.10 (i)

11.10 (i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.

Customer – Regulated User

The customer is responsible for establishing procedural controls that define the employee training process

and requirements which ensure that adequate training is provided to an end user prior to using the GxP

computerized system. The customer is also responsible for ensuring that the adequate education and

experience requirement is met for persons who develop, maintain or use the GxP computerized system(s).

Description of activities, documentation and controls:

Ensure that appropriate training policies are established and that training and personnel qualification are documented (i.e. training records, CV).

Microsoft – Cloud service provider

Microsoft is responsible for maintaining the O365 infrastructure and services that which store electronic

records, therefore must ensure appropriate training policies are established and that training and

personnel qualification are documented (i.e. training records, CV) for personnel managing and monitoring

the O365 services.

Microsoft meets these requirements through the following controls:

Training Management (see Section 2.5.12)

Page 36: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 36 of 74

Document MTM-O365-GDE-01 Revision 01

10.10 (j)

11.10 (j)

The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.

Customer – Regulated User

This requirement would be applicable if the customer has implemented a GxP computerized system which

provides users with the ability to apply electronic signatures to sign electronic records (see definition in

Section 1.5). The customer would in this case be responsible for implementing controls governing the use

of electronic signatures ensuring that individuals are aware that they are accountable and responsible for

actions initiated under their electronic signatures.

Description of activities, documentation and controls:

A written policy should be established that holds individuals accountable and responsible for actions initiated under or authorized by their electronic signatures;

Ensure that appropriate Training policies are established and that training and personnel qualification are documented (i.e. training records, CV).

Microsoft – Cloud service provider

Microsoft does not participate in the generation of electronic records or application of electronic

signatures, therefore does not have any responsibilities with regards to this regulatory requirement.

Page 37: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 37 of 74

Document MTM-O365-GDE-01 Revision 01

11.10 (k)(1)

11.10 (k) Use of appropriate controls over systems documentation including :

11.10 (k)(1)

Adequate controls over the distribution of, access to, and use of documentation for system operation

and maintenance.

Customer – Regulated User

This regulation applies to system documentation which describes how a system operates and is

maintained, including standard operating procedures. Some highly sensitive documentation, such as

instructions on how to modify system security features, should not be widely distributed. Hence, the

customer is responsible for controlling the distribution of, access to, and use of such documentation which

is typically managed via the Document Management and Training Management processes.

Description of activities, documentation and controls:

Procedures governing controlled documentation management should be established in order to ensure that employees have access to the correct and updated versions of standard operating and maintenance procedures for the GxP computerized system configured on the O365 platform;

Ensure that procedural controls are established to appropriately manage the distribution, access and use of system documentation for GxP computerized systems configured on the O365 platform.

Microsoft – Cloud service provider

Microsoft is responsible for ensuring access to system operation and maintenance documentation related to the O365 platform is properly controlled and that adequate controls are established to control the distribution and use of these documents. Employee training is performed in order to ensure proper use of the system documentation.

Microsoft meets these requirements through the following controls:

Documentation / Asset Management (see Section 2.5.11)

Training Management (see Section 2.5.12)

Page 38: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 38 of 74

Document MTM-O365-GDE-01 Revision 01

11.10 (k)(2)

11.10 (k) Use of appropriate controls over systems documentation including :

11.10 (k)(2)

Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.

Customer – Regulated User

The customer is responsible for establishing controls which govern changes to system and corresponding

documentation. Documents within the scope of this requirement include GxP computerized system

specification, design, installation and validation documents and all other system operating procedures and

manuals.

Description of activities, documentation and controls:

Establish procedures for proper documentation management including document change control;

Ensure proper versioning and audit trail controls on GxP computerized systems documentation;

Establish system change control procedures which trigger appropriate documentation revisions for GxP computerized systems.

Microsoft – Cloud service provider

This regulation stipulates any change to Microsoft system’s hardware or software components should be

documented. The Microsoft change control procedure governs the process of applying changes to the

system and associated documentation. Microsoft has implemented Document and Records Management

procedure governing protection and retention of documentation in conjunction with its Asset

Management procedure.

Microsoft meets these requirements through the following controls:

Software Development / Change Management (see Section 2.5.7)

Documentation / Asset Management (see Section 2.5.11)

Page 39: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 39 of 74

Document MTM-O365-GDE-01 Revision 01

Sec. 11.30 Controls for Open System

SEC. 11.30 CONTROLS FOR OPEN SYSTEMS

11.30

Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Such procedures and controls shall include those identified in 11.10, as appropriate and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality.

Customer – Regulated User

The customer is responsible for ensuring that appropriate controls are implemented to ensure record

authenticity, integrity, and confidentiality. These controls include those identified in Section 3.1.2

As the GxP computerized system is hosted and the internet is used to transmit and/or view electronic

records within the O365 platform, in addition to controls for the proper authentication of users (as with a

closed system), there should also be encryption controls (i.e. SSL or VPN) established to ensure that

records that transit across public networks (such as the Internet) cannot be intercepted or interpreted by

unauthorized individuals. Customers are also responsible for determining and implementing encryption

and information rights management requirements for data stored within the GxP computerized system(s).

The customer is responsible for ensuring that appropriate controls are implemented to ensure record

authenticity, integrity, and confidentiality. These controls include those identified in Section 3.1.2.

Description of activities, documentation and controls:

Applications configured within the O365 platform must be assessed for this requirement;

Customer may implement encryption of customer data within the customer’s application;

Ensure that encryption and access controls are established to ensure that the integrity of data is maintained;

System Monitoring – to ensure consistent availability and performance of GxP computerized system.

Microsoft – Cloud service provider

Microsoft is responsible for ensuring controls are established to ensure the authenticity, integrity and confidentiality of data within the O365 platform and during transit. Microsoft provides customers the option of encrypting data transmitted to and from Microsoft data centers over public networks.

Microsoft meets these requirements through the following controls:

Security Policies and Procedures (see Section 2.5.1)

Physical Security (see Section 2.5.2)

Logical Security (see Section 2.5.3)

System Monitoring and Maintenance (see Section 2.5.4)

Confidentiality (see Section 2.5.6)

Page 40: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 40 of 74

Document MTM-O365-GDE-01 Revision 01

3.3 EudraLex Volume 4 Annex 11 Computerised Systems Compliance Assessment

The following table outlines the assessment that was performed on each regulatory requirement of

EudraLex Volume 4 Annex 11 which were identified as in scope in Section 1.2 of this document. The

primary objective of the assessment is to identify the procedural and technical controls that are

required to satisfy the different regulatory requirements.

We further identify which controls fall within the responsibility of Microsoft versus the controls that are

considered the responsibility of the customer when using the O365 platform for regulated GxP

computerized systems.

PRINCIPLE

This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities. The application should be validated; IT infrastructure should be qualified. Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process.

Customer – Regulated User

The customer must interpret this regulation as applying to all GxP computerized systems supporting GxP related activities that will be configured on the O365 platform. The customer is responsible for validating the GxP computerized systems configured to run within the O365 platform.

Microsoft – Cloud service provider

Microsoft’s responsibility towards their customers is to ensure that the components supporting the O365 platform have been developed, verified and deployed in a controlled fashion and managed according to approved procedures.

Page 41: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 41 of 74

Document MTM-O365-GDE-01 Revision 01

1 – Risk Manage ment

GENERAL

1 - Risk Management

Risk management should be applied throughout the lifecycle of the computerised system taking into

account patient safety, data integrity and product quality. As part of a risk management system,

decisions on the extent of validation and data integrity controls should be based on a justified and

documented risk assessment of the computerised system.

Customer – Regulated User

The customer is responsible for ensuring that risk management is part of the process of assessing,

selecting or developing and implementing GxP computerized systems within the O365 platform.

Description of activities, documentation and controls:

Ensure risk management policies are effective and implemented and/or risk management is integrated into the relevant procedures used for the development, deployment and management of GxP computerized systems;

Integrate risk management into your software development lifecycle procedure.

Use a risk based approach when performing and documenting the qualification/validation activities surrounding the deployment of the GxP computerized systems configured on the O365 platform.

Microsoft – Cloud service provider

Microsoft is responsible for ensuring that risk management has been applied in the development,

maintenance and monitoring of its O365 platform.

Microsoft meets this requirement through the following control:

Software Development / Change Management (see Section 2.5.7)

Risk Assessment (see Section 2.5.10)

Page 42: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 42 of 74

Document MTM-O365-GDE-01 Revision 01

2 - Personnel

2 - Personnel

There should be close cooperation between all relevant personnel such as Process Owner, System Owner,

Qualified Persons and IT. All personnel should have appropriate qualifications, level of access and

defined responsibilities to carry out their assigned duties.

Customer – Regulated User

The customer is responsible for ensuring that controls are established to govern the training and the

activities assigned to their personnel. They should also document the method used to confirm or verify an

individual’s qualifications and experience against formal job descriptions to ensure they are qualified to

perform assigned tasks.

The customer is also responsible for ensuring that an individual has a valid user account in order access the

O365 platform and any relevant GxP computerized system. Within both the O365 platform and the GxP

computerized system, user permissions must be managed by the customer’s assigned System

Administrator to specify what areas of the system are accessible to authorized users.

Description of activities, documentation and controls:

Ensure that appropriate training policies are established and that training and personnel qualifications are documented (i.e. training records, CV);

Ensure that personnel are aware of their roles and responsibilities through approved and signed documentation such as Job Descriptions;

User Account Management procedures should be established to govern the assessment, enabling and disabling of IT system user accounts;

Different levels of system access should be formally defined for each GxP application configured within O365 and users should be assigned to the different levels through the User Account Management procedure.

Microsoft – Cloud service provider

Microsoft is responsible for maintaining the O365 platform infrastructure and services which store

customer electronic records, and therefore must ensure appropriate training policies are established and

that training and personnel qualifications are documented (i.e. training records, CV).

Microsoft is responsible for ensuring adequate controls are established to ensure access to the O365

platform is restricted to authorized individuals.

Microsoft meets these requirements through the following controls:

Security Policies and Procedures (see Section 2.5.1)

Physical Security (see Section 2.5.2)

Logical Security (see Section 2.5.3)

Training Management (see Section 2.5.12)

Page 43: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 43 of 74

Document MTM-O365-GDE-01 Revision 01

3 - Supplier s

3.1

3 - Suppliers

3.1 When third parties (e.g. suppliers, service providers) are used e.g. to provide, install, configure,

integrate, validate, maintain (e.g. via remote access), modify or retain a computerised system or related

service or for data processing, formal agreements must exist between the manufacturer and any third

parties, and these agreements should include clear statements of the responsibilities of the third party.

IT-departments should be considered analogous.

Customer – Regulated User

The customer is responsible for assessing third party suppliers that have an impact on relevant GxP

computerized systems. They are responsible for ensuring that controls addressing the identification,

assessment, selection and management of third party suppliers are established.

Description of activities, documentation and controls:

Ensure that a vendor selection process has been defined and is covered within an effective procedure;

Ensure that when needed appropriate contracts are established (i.e. NDA, SLAs);

Ensure that contracts establish clear statements of responsibility;

Ensure that vendor selection evidence and documentation is maintained following governing Record Retention policies.

Microsoft – Cloud service provider

Microsoft would be considered a third party service provider to the client within the context of this

requirement and formal agreements will be in place between the customer and Microsoft which include a

service level agreement which clearly defines responsibility of each party. In addition, Microsoft is

responsible for ensuring that they appropriately document and control the services provided by third party

suppliers within the context of their O365 platform offering.

Microsoft meets these requirements through the following controls:

Documentation / Asset Management (see Section 2.5.11)

Vendor Management (see Section 2.5.14)

Page 44: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 44 of 74

Document MTM-O365-GDE-01 Revision 01

3.2

3 - Suppliers

3.2 The competence and reliability of a supplier are key factors when selecting a product or service

provider. The need for an audit should be based on a risk assessment.

Customer – Regulated User

The customer is responsible for assessing third party suppliers that have an impact on relevant GxP

computerized systems. The level of impact that a supplier may have on a GxP computerized systems

should be part of the supplier assessment process. This should be taken into account in order to determine

the need for a formal audit of the supplier.

Description of activities, documentation and controls:

Establish a vendor selection procedure and an external audit procedure to define when a vendor audit is required;

Ensure that risk assessment is part of the vendor selection process.

Microsoft – Cloud service provider

Microsoft is responsible for ensuring that they appropriately document and control the selection of third

party suppliers of components/services which form part of the O365 platform offering used by customers

to deploy GxP computerized systems.

Microsoft meets these requirements through the following controls:

Documentation / Asset Management (see Section 2.5.11)

Vendor Management (see Section 2.5.14)

Page 45: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 45 of 74

Document MTM-O365-GDE-01 Revision 01

3.3

3 - Suppliers

3.3 Documentation supplied with commercial off-the-shelf products should be reviewed by regulated

users to check that user requirements are fulfilled.

Customer – Regulated User

The customer is responsible for implementing controls ensuring the review of documentation related to

commercial off-the-self applications supporting GxP activities to verify that the system meets user

requirements.

Description of activities, documentation and controls:

Establish procedures for selecting and deploying off the shelf software solutions and services which includes the verification of supplied documentation to ensure the solutions or services meet user requirements.

Microsoft – Cloud service provider

This regulatory requirement does not apply to Microsoft as they are not regulated users of third party

commercial off-the-shelf products.

As Microsoft is the provider of commercial off-the-self products to regulated users, they are required to

provide customers with sufficient documentation to allow the customer to meet this requirement. 3.4

3 - Suppliers

3.4 Quality system and audit information relating to suppliers or developers of software and

implemented systems should be made available to inspectors on request.

Customer – Regulated User

The customer is responsible for implementing appropriate controls which ensure that quality system and

audit information relating to suppliers is available to inspectors.

Description of activities, documentation and controls:

Ensure that quality system and vendor selection evidence and documentation is maintained following governing record management policies.

Microsoft – Cloud service provider

As Microsoft is a third party vendor of cloud services to their customer’s, they are not required to meet

this requirement.

Page 46: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 46 of 74

Document MTM-O365-GDE-01 Revision 01

4 – Validation

4.1

4 - Validation

4.1 The validation documentation and reports should cover the relevant steps of the life cycle.

Manufacturers should be able to justify their standards, protocols, acceptance criteria, procedures and

records based on their risk assessment.

Customer – Regulated User

The customer is responsible for ensuring that GxP computerized systems are defined, developed, verified,

configured, and validated according to approved and effective software development lifecycle procedures.

Description of activities, documentation and controls:

Establish formal risk based software development lifecycle and computer systems validation procedures;

Ensure GxP computerized systems configured on the O365 platform that manage electronic records are validated to confirm they are fit for their intended purpose based on a formal risk assessment;

Document the qualification/validation activities surrounding the deployment of the GxP computerized systems configured on the O365 platform per the formal procedures.

Microsoft – Cloud service provider

Microsoft is not responsible for validation of the GxP computerized systems configured within the O365 platform, as this is the responsibility of the customer. Microsoft is responsible for ensuring that the components used within the O365 platform have been defined, developed, verified, deployed, and validated according to approved and effective software development lifecycle procedures.

Microsoft meets these requirements through the following control:

Software Development / Change Management (see Section 2.5.7)

Page 47: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 47 of 74

Document MTM-O365-GDE-01 Revision 01

4.2

4 - Validation

4.2 Validation documentation should include change control records (if applicable) and reports on any

deviations observed during the validation process.

Customer – Regulated User

The customer is responsible for ensuring that controls are established to govern the management of issues

encountered within the validation process, along with the administration of changes to GxP computerized

systems and corresponding documentation.

The customer’s validation process should also describe methods used to track and manage deviations and

issues encountered within the validation process. Additional details regarding the qualification / validation

activities are provided in Section 3.1.2.

Description of activities, documentation and controls:

Ensure computer system validation and change control procedures are established, including specific security controls;

Ensure that documentation management controls are established to manage documents produced within the validation and change management processes;

Documents within the scope of this requirement include validation, change control and deviation documents.

Microsoft – Cloud service provider

Microsoft is responsible for ensuring that controls are established to manage the deployment and

verification of customer instances of O365.

Microsoft is also responsible for the implementation of upgrades or patches to the O365 platform. Any

changes to hardware or software components supporting the O365 platform should be documented and

tested prior to being placed into production.

Microsoft meets these requirements through the following controls:

Software Development / Change Management (see Section 2.5.7)

Page 48: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 48 of 74

Document MTM-O365-GDE-01 Revision 01

4.3

4 - Validation

4.3 An up to date listing of all relevant systems and their GMP functionality (inventory) should be

available.

For critical systems an up to date system description detailing the physical and logical arrangements,

data flows and interfaces with other systems or processes, any hardware and software pre-requisites,

and security measures should be available.

Customer – Regulated User

The customer is responsible for ensuring that controls are established to determine the need and content

of system documentation required to manage applicable GxP computerized systems.

Description of activities, documentation and controls:

Produce system description document for all GxP computerized systems, including O365 and relevant systems, which describes hardware requirements, software requirements, system components, data flow and system interfaces;

Reference the O365 platform that will be used to deploy the GxP computerized system in the system description document.

Microsoft – Cloud service provider

As customers may implement critical GxP computerized systems within the O365 platform, Microsoft is

responsible for ensuring the management of assets within the GFS environment supporting the O365

platform.

Microsoft meets this requirement through the following control:

Documentation / Asset Management (see Section 2.5.11)

Page 49: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 49 of 74

Document MTM-O365-GDE-01 Revision 01

4.4

4 - Validation

4.4 User Requirements Specifications should describe the required functions of the computerised

system and be based on documented risk assessment and GMP impact. User requirements should be

traceable throughout the life-cycle

Customer – Regulated User

The customer is responsible for ensuring that controls are in place which define the method for gathering

and documenting the needs of their users. The approach must include the assessment and mitigation of

risk and regulatory impact. The customer’s documented User Requirements must be traced throughout

the GxP computerized system’s lifecycle.

Description of activities, documentation and controls:

Establish procedures for the development and management of user requirements;

Establish traceability mechanisms for user requirements.

Microsoft – Cloud service provider

This regulatory requirement does not apply to Microsoft as they are not users of regulated computerized

systems.

Page 50: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 50 of 74

Document MTM-O365-GDE-01 Revision 01

4.5

4 - Validation

4.5 The regulated user should take all reasonable steps, to ensure that the system has been developed

in accordance with an appropriate quality management system. The supplier should be assessed

appropriately

Customer – Regulated User

The customer is responsible for ensuring that controls addressing the management of third party suppliers

are established. The customer must also ensure that regulated systems have been developed according to

or meet the requirements of an approved SDLC process.

Description of activities, documentation and controls:

Ensure that a vendor selection process has been defined and is covered within an effective procedure;

Ensure that when needed appropriate contracts are established (i.e. NDA, SLAs);

Ensure that vendor selection evidence and documentation is maintained following governing Record Retention policies;

Ensure that the vendors quality system has the appropriate controls in place to govern the SDLC process;

Ensure that system development activities are performed as defined within the governing the SDLC or computer system validation procedure.

Microsoft – Cloud service provider

This regulatory requirement does not apply to Microsoft as they are not users of regulated computerized

systems.

As Microsoft is the provider of commercial off-the-self products to regulated users, they are required to

provide these customer’s with sufficient documentation to allow the customer to meet this requirement.

Page 51: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 51 of 74

Document MTM-O365-GDE-01 Revision 01

4.6

4 - Validation

4.6 For the validation of bespoke or customised computerised systems there should be a process

established that ensures the formal assessment and reporting of quality and performance measures for

all the life-cycle stages of the system.

Customer – Regulated User

The customer is responsible for establishing controls that will ensure the continuous assessment and

measurement of quality and performance throughout the GxP computerized system’s lifecycle.

Description of activities, documentation and controls:

Ensure computer system validation and change control policies are established.

Microsoft – Cloud service provider

As customers may implement GxP computerized systems within the O365 platform, Microsoft is

responsible for establishing appropriate controls to ensure the monitoring and change management of

assets supporting the O365 platform.

Microsoft meets these requirements through the following controls:

System Monitoring and Maintenance (see Section 2.5.4)

Software Development / Change management (see Section 2.5.7)

Page 52: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 52 of 74

Document MTM-O365-GDE-01 Revision 01

4.7

4 - Validation

4.7 Evidence of appropriate test methods and test scenarios should be demonstrated. Particularly,

system (process) parameter limits, data limits and error handling should be considered. Automated

testing tools and test environments should have documented assessments for their adequacy.

Customer – Regulated User

The customer is responsible for establishing appropriate controls to govern the testing of their GxP

computerized systems and that relevant tests are performed and adequately documented.

Description of activities, documentation and controls:

Ensure adequate computer system validation and change control policies are established;

Ensure that all testing activities are properly documented.

Microsoft – Cloud service provider

As customers may implement GxP computerized systems within the O365 platform, Microsoft is

responsible for establishing appropriate controls to ensure the controlled and verified deployment of the

underlying infrastructure that supports the O365 platform.

Microsoft meets these requirements through the following controls:

System Monitoring and Maintenance (see Section 2.5.4)

Software Development / Change Management (see Section 2.5.7)

4.8

4 - Validation

4.8 If data are transferred to another data format or system, validation should include checks that

data are not altered in value and/or meaning during this migration process.

Customer – Regulated User

The customer is responsible for establishing appropriate controls to ensure that the process of data

migration is tested and documented accordingly when migrating data to/from GxP computerized systems

configured on the O365 platform.

Description of activities, documentation and controls:

Establish change management procedures which govern data migration;

Establish data migration plans which include controls for the verification that data has not altered in value and/or meaning following migration.

Microsoft – Cloud service provider

Microsoft is not responsible for the migration of data between GxP computerized systems configured on

the O365 platform.

Page 53: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 53 of 74

Document MTM-O365-GDE-01 Revision 01

5 – Data

OPERATIONAL PHASE

5 - Data

Computerised systems exchanging data electronically with other systems should include appropriate

built-in checks for the correct and secure entry and processing of data, in order to minimize the risks.

Customer – Regulated User

The customer is responsible for establishing the controls required to ensure the authenticity, integrity and

confidentiality of data related to GxP computerized systems configured within the O365 platform. In

addition to controls for the proper authentication of users (as with a closed system), there should also be

encryption controls (i.e. SSL or VPN) established to ensure that records that transit across public networks

(such as the Internet) cannot be intercepted or interpreted by unauthorized individuals. These controls

should include related topics as identified in Section 3.1.2.

Description of activities, documentation and controls:

Applications configured within the O365 platform must be assessed to this requirement;

Ensure that encryption and access controls are established to ensure that the integrity of data is maintained within the GxP computerized system and when data is transiting from the O365 platform across the internet.

Microsoft – Cloud service provider

Microsoft is responsible for implementing adequate controls to secure the O365 platform and provide

appropriate system monitoring. By securing and monitoring the O365 platform, these controls help to

satisfy the above regulatory requirement, such that the GxP computerized systems configured on the

O365 platform are protected. Microsoft provides customers the option of encrypting data transmitted to

and from Microsoft data centers over public networks.

Microsoft meets these requirements through the following controls:

Security Policies and Procedures (see Section 2.5.1)

Physical Security (see Section 2.5.2)

Logical Security (see Section 2.5.3)

System Monitoring and Maintenance (see Section 2.5.4)

Confidentiality (see Section 2.5.6)

Page 54: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 54 of 74

Document MTM-O365-GDE-01 Revision 01

6 – Accura cy Che cks

6 - Accuracy Checks

For critical data entered manually, there should be an additional check on the accuracy of the data. This

check may be done by a second operator or by validated electronic means. The criticality and the

potential consequences of erroneous or incorrectly entered data to a system should be covered by risk

management.

Customer – Regulated User

The customer is responsible for implementing controls to ensure that data entered into GxP computerized

systems are accurate. Verification controls should be implemented to determine the risk and impact that

inaccurate or mistakenly entered data would have on the GxP computerized system.

Description of activities, documentation and controls:

Ensure GxP computerized have controls for detecting inaccurate or erroneous data.

Microsoft – Cloud service provider

This requirement is the customer’s responsibility as Microsoft is not providing GxP computerized systems

used for data entry.

Page 55: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 55 of 74

Document MTM-O365-GDE-01 Revision 01

7 - Data Storage

7.1

7 - Data Storage

7.1 Data should be secured by both physical and electronic means against damage. Stored data should

be checked for accessibility, readability and accuracy. Access to data should be ensured throughout the

retention period.

Customer – Regulated User

The customer is responsible to ensure adequate authority checks are implemented where necessary

through the application of security policies and the centralized management of user permissions with the

GxP computerized system. The customer is also responsible for ensuring that appropriate controls are

established to protect data and records pertaining to GxP activities performed within GxP computerized

systems configured on the O365 platform, and to ensure accurate data is readily available throughout its

retention period.

Description of activities, documentation and controls:

The verification that only authorized users are able to access, read and alter records contained within the GxP computerized system should be performed as part of the validation effort;

Procedure(s) are established governing the following topics:

o Logical security - describes the security controls which are required in order to prevent unauthorized access to the application;

o User Account Management - describes the process for requesting new user accounts and how to provide end users with relevant permissions;

o Data backup and recovery - describes the process for the backup and recovery of data housed within the O365 platform;

o Records retention and archiving - describes how records will be protected and archived throughout their lifecycle;

Ensure that mechanisms for Disaster Recovery and Business Continuity are established and tested, should any issue arise with the Azure VMs;

Data repatriation plan are established and tested in the case of contract termination.

Page 56: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 56 of 74

Document MTM-O365-GDE-01 Revision 01

7 - Data Storage

7.1 Data should be secured by both physical and electronic means against damage. Stored data should

be checked for accessibility, readability and accuracy. Access to data should be ensured throughout the

retention period.

Microsoft – Cloud service provider

Microsoft manages the security component which authenticates users of the O365 platform, therefore is

responsible for ensuring proper controls are established to securely manage the user access control

system along with the physical elements housing customer records.

Microsoft is responsible for implementing adequate controls to secure the O365 platform and provide

appropriate system monitoring. By securing and monitoring the O365 platform, these controls help to

satisfy the above regulatory requirement, such that the GxP computerized systems are protected and are

continually available.

Microsoft meets these requirements through the following controls:

Security Policies and Procedures (see Section 2.5.1)

Physical Security (see Section 2.5.2)

Logical Security (see Section 2.5.3)

System Monitoring and Maintenance (see Section 2.5.4)

Data Backup, Recovery and Retention (see Section 2.5.5)

Service Level Agreements (see Section 2.5.9)

Page 57: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 57 of 74

Document MTM-O365-GDE-01 Revision 01

7.2

7 - Data Storage

7.2 Regular back-ups of all relevant data should be done. Integrity and accuracy of backup data and

the ability to restore the data should be checked during validation and monitored periodically.

Customer – Regulated User

The customer is responsible for defining the backup scheme for data housed within GxP computerized

systems which are configured on the O365 platform and ensuring that the implemented backup

mechanism functions appropriately and consistently.

Description of activities, documentation and controls:

Ensure that controls and procedures are established to oversee the backup and recovery of data. These controls should be tested periodically to ensure that they are still functional;

Ensure data repatriation plans are established and tested in the case of contract termination.

Microsoft – Cloud service provider

Microsoft is responsible for ensuring that appropriate controls are in place to manage the backup systems

and provide assurance to customers that their defined backup schemes are implemented and function

correctly and will provide the expected level of retention. Controls to govern the maintenance and

verification of the backup system should be implemented.

Microsoft meets these requirements through the following controls:

System Monitoring and Maintenance (see Section 2.5.4)

Data Backup, Recovery and Retention (see Section 2.5.5)

Page 58: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 58 of 74

Document MTM-O365-GDE-01 Revision 01

8 – Printouts

8.1

8 - Printouts

8.1 It should be possible to obtain clear printed copies of electronically stored data.

Customer – Regulated User

The customer is responsible for ensuring that GxP computerized systems configured on the O365 platform

are capable of generating accurate and complete copies of records.

Description of activities, documentation and controls:

Procedure(s) are established governing the protection of records to ensure accurate and complete copies are readily available;

Verify accurate and complete copies of electronic records can be retrieved and printed from the system during validation;

Verify data transfer from applications which store electronic records in GxP computerized systems configured on the O365 platform does not impact data integrity.

Microsoft – Cloud service provider

Microsoft is not responsible for ensuring it is possible to print copies of customer data stored within the

GxP computerized systems configured on the O365 platform. However, Microsoft is responsible for

implementing adequate controls to secure the O365 platform and provide appropriate system monitoring.

By securing and monitoring the O365 platform, these controls help to satisfy the above regulatory

requirement, such that the GxP computerized systems are protected are continually available.

Microsoft meets these requirements through the following controls:

Security Policies and Procedures (see Section 2.5.1)

Physical Security (see Section 2.5.2)

Logical Security (see Section 2.5.3)

System Monitoring and Maintenance (see Section 2.5.4)

Service Level Agreements (see Section 2.5.9)

Page 59: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 59 of 74

Document MTM-O365-GDE-01 Revision 01

8 - Printouts

8.2 For records supporting batch release it should be possible to generate printouts indicating if any of

the data has been changed since the original entry.

Customer – Regulated User

The customer should ensure that GxP computerized systems configured on the O365 platform have been

assessed and are capable of fulfilling this requirement. This requirement is typically met through the

generation of audit trails for batch records and ensuring that the batch records with audit trail can be

printed.

Microsoft – Cloud service provider

Microsoft is not responsible for customer data stored within the GxP computerized systems configured on

the O365 platform. However, Microsoft is responsible for implementing adequate controls to secure the

O365 platform and provide appropriate system monitoring. By securing and monitoring the O365

platform, these controls help to satisfy the above regulatory requirement, such that the GxP computerized

systems are protected and are continually available.

Microsoft meets these requirements through the following controls:

Security Policies and Procedures (see Section 2.5.1)

Physical Security (see Section 2.5.2)

Logical Security (see Section 2.5.3)

System Monitoring and Maintenance (see Section 2.5.4)

Service Level Agreements (see Section 2.5.9)

Page 60: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 60 of 74

Document MTM-O365-GDE-01 Revision 01

9 – Audit Trails

9 - Audit Trails

Consideration should be given, based on a risk assessment, to building into the system the creation of a

record of all GMP-relevant changes and deletions (a system generated "audit trail"). For change or

deletion of GMP-relevant data the reason should be documented. Audit trails need to be available and

convertible to a generally intelligible form and regularly reviewed.

Customer – Regulated User

The O365 environment provides a standard audit trail feature. This feature must be turned on and

configured as part of the installation process for GxP computerized system configured on the O365

platform (see section 2.2. for more information).

Description of activities, documentation and controls:

Verify that audit trails are being properly generated for electronic records within O365 based on this requirement;

Verify that audit trail entries can be retrieved and that audit trail entries remain linked to their respective records throughout their retention period;

Verify that the audit trail can be retrieved as a human readable record;

Ensure Procedure(s) are established governing the following activities:

o Record retention and archiving - should define how audit trails will be protected throughout their corresponding records lifetime;

o Logical security – to ensure adequate protection and integrity of audit trails as electronic records in their own right;

o System Administration procedures for the GxP computerized systems configured on the O365 platform to ensure the proper management of audit trails.

Microsoft – Cloud service provider

Customers are responsible for ensuring that the audit trail functionality provided in the O365 platform is

properly configured. Microsoft is responsible for implementing adequate controls to secure the O365

platform and provide appropriate system monitoring. By securing and monitoring the O365 platform,

these controls help to satisfy the above regulatory requirement, such that the GxP computerized systems

are protected and are continually available.

Microsoft meets these requirements through the following controls:

Security Policies and Procedures (see Section 2.5.1)

Physical Security (see Section 2.5.2)

Logical Security (see Section 2.5.3)

System Monitoring and Maintenance (see Section 2.5.4)

Service Level Agreements (see Section 2.5.9)

Page 61: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 61 of 74

Document MTM-O365-GDE-01 Revision 01

10 – Cha nge and Configuration Manage ment

10 - Change and Configuration Management

Any changes to a computerised system including system configurations should only be made in a

controlled manner in accordance with a defined procedure.

Customer – Regulated User

The customer is responsible for establishing controls to govern the change and configuration management

processes related to GxP computerized systems configured on the O365 platform.

Description of activities, documentation and controls:

Ensure that appropriate System Change Control, Configuration Management, Application Quality and Security procedures along with documentation management controls are established.

Microsoft – Cloud service provider

Microsoft is responsible for ensuring that controls are in place to govern the management of the

underlying O365 system components used for GxP computerized systems configured on the O365

platform.

Microsoft meets these requirements through the following controls:

Software Development / Change Management (see Section 2.5.7)

Page 62: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 62 of 74

Document MTM-O365-GDE-01 Revision 01

11 – Periodi c evaluation

11 - Periodic evaluation

Computerised systems should be periodically evaluated to confirm that they remain in a valid state and

are compliant with GMP. Such evaluations should include, where appropriate, the current range of

functionality, deviation records, incidents, problems, upgrade history, performance, reliability, security

and validation status reports.

Customer – Regulated User

The customer is responsible for ensuring that controls are established to govern the maintenance of the

GxP computerized systems’ validated state throughout its lifecycle. These controls should include related

topics as identified in Section 3.1.2.

Description of activities, documentation and controls:

Ensure computer system validation and change control policies are established for GxP computerized systems configured on the O365 platform;

Ensure that systems maintenance procedures are in place to manage GxP computerized systems configured on the O365 platform;

Ensure that deviation and incident management procedures are in place to manage deviations, incidents and problems that arise with GxP computerized systems configured on the O365 platform.

Microsoft – Cloud service provider

Microsoft is not responsible for validation of systems to verify compliance with GxP regulations. However,

Microsoft is responsible for implementing adequate controls to secure the O365 platform and provide

appropriate system monitoring. By securing and monitoring the O365 platform, these controls help to

satisfy the above regulatory requirement, such that the GxP computerized systems configured on the

O365 platform are protected and are continually available.

Microsoft meets these requirements through the following controls:

Security Policies and Procedures (see Section 2.5.1)

Physical Security (see Section 2.5.2)

Logical Security (see Section 2.5.3)

System Monitoring and Maintenance (see Section 2.5.4)

Service Level Agreements (see Section 2.5.9)

Page 63: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 63 of 74

Document MTM-O365-GDE-01 Revision 01

12 – Security

12.1

12 - Security

12.1 Physical and/or logical controls should be established to restrict access to computerised system to

authorised persons. Suitable methods of preventing unauthorised entry to the system may include the

use of keys, pass cards, personal codes with passwords, biometrics, restricted access to computer

equipment and data storage areas.

Customer – Regulated User

The customer is responsible for ensuring that an individual has a valid user account in order to access the

O365 platform and GxP computerized system. Within the O365 platform and GxP computerized system,

user permissions must be managed by the System Administrator to specify which areas of the system are

accessible to each user.

Description of activities, documentation and controls:

Ensure proper procedures are established to govern logical and physical security. The procedure should clearly describe how access to the system is managed, as well as how user system access is documented;

A procedure describing the process for requesting new user accounts and how to provide the correct permissions should be developed;

The verification that only authorized users are able to access and alter records contained within the system should be performed as part of the validation effort;

Appropriate System Administration practices are followed for applications configured on the O365 platform;

Ensure that encryption and access controls are established to ensure that the integrity of data is maintained.

Microsoft – Cloud service provider

Microsoft is responsible for ensuring adequate controls are established to ensure access to the Azure

infrastructure components is restricted to authorized individuals.

Microsoft meets these requirements through the following controls:

Security Policies and Procedures (see Section 2.5.1)

Physical Security (see Section 2.5.2)

Logical Security (see Section 2.5.3)

Page 64: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 64 of 74

Document MTM-O365-GDE-01 Revision 01

12.2

12 - Security

12.2 The extent of security controls depends on the criticality of the computerised system.

Customer – Regulated User

The customer is responsible for establishing controls to ensure that appropriate security controls are

implemented. The level and complexity of security controls should be based on the GxP impact of the GxP

computerized system.

Description of activities, documentation and controls:

Ensure proper procedures are established to govern logical and physical security;

Ensure risk management policies are established

Microsoft – Cloud service provider

Microsoft is responsible for implementing adequate controls to secure the O365 platform and provide

appropriate system monitoring. By securing and monitoring the O365 platform, these controls help to

satisfy the above regulatory requirement, such that the GxP computerized systems configured on the

O365 platform are protected and are continually available. .

Microsoft meets these requirements through the following controls:

Security Policies and Procedures (see Section 2.5.1)

Physical Security (see Section 2.5.2)

Logical Security (see Section 2.5.3)

Risk Assessment (see Section 2.5.10)

Page 65: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 65 of 74

Document MTM-O365-GDE-01 Revision 01

12.3

12 - Security

12.3 Creation, change, and cancellation of access authorisations should be recorded.

Customer – Regulated User

The customer is responsible for ensuring that the management of user accounts is controlled and

documented. It should be noted that user accounts should not be deleted but deactivated, allowing

traceability within electronic records to be maintained. This control of access also applies to physical

components related to the GxP computerized systems (i.e. computer rooms, office space, server rooms)

which must equally be controlled and documented.

Description of activities, documentation and controls:

Ensure proper procedures are established to govern logical and physical security. The procedure should clearly describe how access to GxP computerized systems is managed;

Establish a user access control list to record all granting of, changes to or cancellation of user access to GxP computerized systems;

Ensure appropriate System Administration practices are followed for GxP computerized systems configured on the O365 platform.

Microsoft – Cloud service provider

Microsoft is not responsible for validation of systems to verify compliance with GxP regulations. However,

Microsoft is responsible for implementing adequate controls to secure the O365 platform and provide

appropriate system monitoring. By securing and monitoring the O365 platform, these controls help to

satisfy the above regulatory requirement, such that the GxP computerized systems configured on the

O365 platform are protected and are continually available.

Microsoft meets these requirements through the following controls:

Security Policies and Procedures (see Section 2.5.1)

Physical Security (see Section 2.5.2)

Logical Security (see Section 2.5.3)

Page 66: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 66 of 74

Document MTM-O365-GDE-01 Revision 01

12.4

12 - Security

12.4 Management systems for data and for documents should be designed to record the identity of

operators entering, changing, confirming or deleting data including date and time.

Customer – Regulated User

The GxP computerized systems configured on the O365 platform should capture the identity of users

creating or performing actions on data. The information captured should include the following:

Date and time when electronic records are created, initiated, changed, confirmed, and deleted;

The identity of the user who performed the action.

Description of activities, documentation and controls:

Procedure(s) are established governing the following activities:

o The defined Computer System Validation process should ensure that this requirement is present and functions in the GxP computerized system.

Microsoft – Cloud service provider

This regulatory requirement does not apply to Microsoft as they are not users of regulated computerized systems for the collection and management of regulated electronic records.

13 - Incide nt Management

13 - Incident Management

All incidents, not only system failures and data errors, should be reported and assessed. The root cause

of a critical incident should be identified and should form the basis of corrective and preventive actions.

Customer – Regulated User

The customer is responsible for ensuring that appropriate tools or controls are established to govern the

documentation, assessment and tracking of reported issues related to GxP computerized systems. These

controls should include related topics as identified in Section 3.1.2.

Description of activities, documentation and controls:

Ensure that procedural controls such as incident management and CAPA are implemented to manage all incidents related to GxP computerized systems.

Microsoft – Cloud service provider

Microsoft is responsible for ensuring that appropriate tools or controls are established to govern the documentation, assessment and tracking of reported issues related to the O365 platform on which GxP computerized systems are configured.

Microsoft meets these requirements through the following controls:

Incident Management (see Section 2.5.8)

Service Level Agreements (see Section 2.5.9)

Page 67: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 67 of 74

Document MTM-O365-GDE-01 Revision 01

14 - Electr onic Signature

14 - Electronic Signature

Electronic records may be signed electronically. Electronic signatures are expected to:

a. have the same impact as hand-written signatures within the boundaries of the company,

b. be permanently linked to their respective record,

c. include the time and date that they were applied.

Customer – Regulated User

The customer is responsible for ensuring through verification that GxP computerized systems configured

within the O365 platform applying electronic signatures meet this requirement.

Description of activities, documentation and controls:

Ensure that the use and elucidation of Electronic Signatures are defined within a procedural control;

Ensure procedure controls are established to govern the assignment of Electronic Signatures.

Microsoft – Cloud service provider

This regulatory requirement does not apply to Microsoft as this functionality is not provided as a part of the O365 platform.

15 - Bat ch release

15 - Batch release

When a computerised system is used for recording certification and batch release, the system should

allow only Qualified Persons to certify the release of the batches and it should clearly identify and record

the person releasing or certifying the batches. This should be performed using an electronic signature.

Customer – Regulated User

The customer is responsible for ensuring that GxP computerized systems to be implemented within the

O365 platform have been assessed to this requirement.

Description of activities, documentation and controls:

The defined Computer System Validation process should ensure that this requirement is assessed and appropriate supporting documentation must be produced;

Ensure that controls have been defined and implemented to govern the use of electronic signatures.

Microsoft – Cloud service provider

This requirement does not apply to Microsoft. Microsoft does not have direct control over GxP activities, as these would be implemented within GxP computerized systems that are configured and managed by the customer on the O365 platform.

Microsoft does not provide electronic signature functionality as part of the O365 platform.

Page 68: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 68 of 74

Document MTM-O365-GDE-01 Revision 01

16 - Busine ss Continuity

16 - Business Continuity

For the availability of computerised systems supporting critical processes, provisions should be made to

ensure continuity of support for those processes in the event of a system breakdown (e.g. a manual or

alternative system). The time required to bring the alternative arrangements into use should be based

on risk and appropriate for a particular system and the business process it supports. These arrangements

should be adequately documented and tested.

Customer – Regulated User

The customer is responsible for ensuring that mechanisms for Disaster Recovery and Business Continuity

are established and tested, should any issue arise with either the GxP computerized system or with the

O365 platform.

Description of activities, documentation and controls:

Establish a comprehensive disaster recovery and business continuity plan and test it regularly. This plan should include provisions in the case that the O365 platform becomes unavailable. The plan should also integrate risk and impact assessment mechanisms;

Ensure that backup infrastructure and policies are established and have been tested for GxP computerized systems configured on the O365 platform;

Ensure the data repatriation plans are established and tested.

Microsoft – Cloud service provider

Microsoft is responsible for implementing adequate controls to ensure the O365 platform remains

available in the event of disaster. Backup and retention policies/procedures are defined and maintained in

accordance to regulatory, statutory, contractual or business requirements. These controls help to satisfy

the above regulatory requirement, such that Microsoft backs up O365 infrastructure data regularly and

validates restoration of data periodically for disaster recovery purposes.

Microsoft meets these requirements through the following controls:

System Monitoring and Maintenance (see Section 2.5.4)

Data Backup, Recovery and Retention (see Section 2.5.5)

Service Level Agreements (see Section 2.5.9)

Disaster Recovery (see Section 2.5.13)

Page 69: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 69 of 74

Document MTM-O365-GDE-01 Revision 01

17 - Archiving

17 - Archiving

Data may be archived. This data should be checked for accessibility, readability and integrity. If relevant

changes are to be made to the system (e.g. computer equipment or programs), then the ability to

retrieve the data should be ensured and tested.

Customer – Regulated User

The customer is responsible for establishing controls to implement appropriate archiving mechanisms.

Archived data should be regularly verified to ensure its accessibility, readability and integrity.

Description of activities, documentation and controls:

Ensure that appropriate security controls are established;

Ensure that backup infrastructure and policies are established and have been tested for GxP computerized systems configured on the O365 platform;

Ensure that record retention policies have been defined;

Ensure that mechanism for Disaster Recovery and Business Continuity are established and tested, should any issue arise with the O365 platform;

Data repatriation plan are established and tested;

Ensure that audit trails have been properly defined and verified.

Microsoft – Cloud service provider

Microsoft is not responsible for archiving data contained within the GxP computerized systems hosted on

the O365 platform. However, Microsoft is responsible for implementing adequate controls to secure the

O365 platform and provide appropriate system monitoring. By protecting and monitoring the O365

platform, these controls help to satisfy the above regulatory requirement, such that the GxP computerized

systems are protected and are continually available.

Microsoft meets these requirements through the following controls:

Security Policies and Procedures (see Section 2.5.1)

Physical Security (see Section 2.5.2)

Logical Security (see Section 2.5.3)

System Monitoring and Maintenance (see Section 2.5.4)

Data Backup, Recovery and Retention (see Section 2.5.5)

Service Level Agreements (see Section 2.5.9)

Page 70: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 70 of 74

Document MTM-O365-GDE-01 Revision 01

4 Conclusion

In summary, when considering the use of a public, off-premise, third party managed cloud service to

host GxP computerized systems it is important to assess the adequacy of the cloud service provider’s

controls which ensure confidentiality, integrity and availability of customer data. Defining roles and

responsibilities shared between the regulated user and the cloud service provider is essential.

As outlined within this guidance document, Microsoft has implemented procedural and technical

controls which are relevant to regulatory requirements stipulated within US FDA 21 CFR Part 11 and

EudraLex Volume 4 Annex 11. These controls have been independently audited and could serve to

demonstrate that the O365 platform is maintained in a state of control that is in accordance with the

applicable regulatory requirements. The assessment has shown that the audited controls are similar to

those required to satisfy the applicable regulatory requirements, therefore the customer may leverage

these audits as part of the risk analysis and qualification effort of their GxP computerized system

configured on the O365 platform.

Of equal importance are the activities and controls which must be implemented by the customer to

ensure that GxP computerized systems are maintained in a secured and qualified state. A summary of

these activities was provided in Section 3.1.2. The customer should identify the specific activities within

a qualification plan for each GxP computerized system configured on the O365 platform. In order to

qualify the system and maintain it in a qualified state, Montrium recommends implementing

procedures/policies which cover the topics as outlined in Appendix A.

Page 71: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 71 of 74

Document MTM-O365-GDE-01 Revision 01

5 References

Ref ID Reference

Ref. [1] Report on a Description of Microsoft Office 365 and Office 365 Dedicated’s System and the

Suitability of the Design and Operating Effectiveness of Controls (SOC 1)

Ref. [2] Report on Controls at a Service Organization Relevant to Security (SOC 2)

Ref. [3] Assessment Report Microsoft Office 365, ISO/IEC 27001:2005, IS 552878

Ref. [4] U.S. Food and Drug Administration, Code of Federal Regulations, Title 21 Part 11, Electronic

Records; Electronic Signatures.

Ref. [5] U.S. Food and Drug Administration, Guidance for Industry - Part 11, Electronic Records;

Electronic Signatures - Scope and Application.

Ref. [6] ISPE, GAMP 5 - A Risk-Based Approach to Compliant GxP computerized systems, 2008.

Ref. [7] ISPE, GAMP Good Practice Guide: IT Infrastructure Control and Compliance

Ref. [8] EudraLex The Rules Governing Medicinal Products in the European Union - Volume 4 - Good

Manufacturing Practice - Medicinal Products for Human and Veterinary Use- Annex 11:

Computerised Systems

Ref. [9] NIST Cloud Computing Standards Roadmap

Ref. [10] O365™ Security White Paper

Ref. [11] Appendix B: Trust Services Principles and Criteria for Security, Availability,

Processing Integrity, Confidentiality, and Privacy

Ref. [12] Validation Guidance for FDA Regulated Companies

Ref. [13] Standard Response to Request for Information Security and Privacy

Ref. [14] Microsoft Server Tools Business Information Security Policy

Ref. [15] Cloud Security Alliance, Security Guidance for Critical Areas of Focus on Cloud Computing, V3.0

Ref. [16] Cloud Security Alliance “Cloud Controls Matrix (CCM)”

Ref. [17] PIC / S PI 011-3 - Good Practices for Computerised Systems in Regulated “GxP” Environments

Ref. [18] Introducing Windows Azure

Ref. [19] O365 Privacy Statement

Ref. [20] Microsoft Volume Licensing - Online Services Use Rights, April 2013

Page 72: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 72 of 74

Document MTM-O365-GDE-01 Revision 01

6 Appendices

Appendix A. Recommended Procedures / Policies

Page 73: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 73 of 74

Document MTM-O365-GDE-01 Revision 01

Appendix A - Recommended Procedures / Policies

The following topics should be covered within the customer’s internal procedures or policies to manage

the qualified state of the GxP system.

Procedure / Policy Topic Purpose

Computer Systems

Validation

Define the management of the validation of computer systems and so

must describe the activities, deliverables and individuals required to

achieve and maintain computer systems in a validated state and in

compliance with applicable GxP regulations.

Physical Security Describe the company’s application of security measures to facilities

(buildings, server rooms, laboratory and other controlled physical

environments), in order to protect data and users.

Logical Security Describe the company’s application of security measures to all

information technology systems in order to protect data and users.

System Monitoring Describe the tools used to monitor the systems to ensure consistent

availability and performance.

Records Retention and

Archiving

Ensure that all the company’s records are managed in conformance with

applicable regulations and requirements. This should include the

identification, classification and retrieval, storage and protection, receipt

and transmission, retention, and disposal or archival preservation of

records.

System Administration and

Maintenance

Provide the company’s personnel direction on the technical

management and engineering practices to be used in planning,

acquisition, operation, maintenance, and termination of information

technology systems.

User Access Management Describe the management of computing accounts that facilitate access

or changes to the company’s data. An account, at a minimum, consists of

a username and password; supplying account information will usually

grant access to the company’s resources. User access management also

establishes clear standards for issuing accounts, creating password

values, and managing accounts.

Backup and Restoration Provide for the continuity, restoration and recovery of critical

documents, all electronic records and systems in the event of an

equipment failure, intentional destruction of data or disaster.

Page 74: Qualification Guideline for Microsoft Office 365 · PDF filean emphasis on the concepts presented and described within ISPE’s, GAMP® series of Good Practice ... Qualification Guideline

Qualification Guideline for Microsoft Office 365

© 2013 Montrium Inc. Page 74 of 74

Document MTM-O365-GDE-01 Revision 01

Procedure / Policy Topic Purpose

Training Management Define an internal training program and to ensure that personnel have

the competencies required to access and work within the application

contained within the controlled cloud platform. Additional training needs

may need to be defined for each controlled application within the cloud

platform.

Documentation

Management

Establish the framework under which official records and documents are

created and managed. The intent is to ensure that the company’s

business areas have the appropriate governance and supporting

structure and resources established to enable them to manage their

records and documents in a manner that is planned, controlled,

monitored, recorded and audited, using authorized systems.

Incident and Problem

Management (Helpdesk)

Define a formal Helpdesk Process to ensure that issues are raised,

recorded and resolved in a formal and controlled manner

Change / Configuration

Management

Define a formal process for change management that will ensure that

system changes are implemented in a controlled fashion. This procedure

must also establish the framework for proposing, reviewing, and

approving changes to a system.

The purpose for addressing Configuration Management is to ensure that

all updates to baseline items are controlled and traceable.

Vendor Management Define a formal process to ensure that vendor’s are identified, assessed,

selected and managed in a formal and controlled manner.

Disaster Recovery and

Business Continuity

Assist in the recovery of the company’s information technology

infrastructure and to ensure the continued operation of identified

business critical systems in the event of a serious disruption.