Windchill Product Quality SaaS Overview 1. Introduction · 2018-12-18 · Windchill Product Quality...

Windchill Product Quality SaaS Overview

PTC October 1, 2018 of 11

1. Introduction

The scope of this document is to describe the PTC medical device branded solution Windchill

Product Quality (WPQ) Software-as-a-Service (SaaS) and the processes for delivery of the WPQ

SaaS offering. The offering is available only as SaaS through the PTC Cloud Services and

enabled by the PTC Partner program.

The document will focus on:

• WPQ SaaS solution overview, licensing, and add-ons

• Describe how Partners will work with the Customer, PTC Cloud, and third-party validation

services to deliver the WPQ validated solution

• Extending Windchill with ThingWorx Navigate

• Frequently Asked Questions (FAQ)

1.1 WPQ SaaS Solution Overview

Windchill Product Quality is a purpose-built offering for life science, medical device and

biomedical customers. It extends PTC’s Windchill PLM platform by offering a ‘validation ready’

PLM SaaS solution incorporating functionality and best-practices for meeting regulatory

requirements from organizations such as the US Food and Drug Administration (FDA) and the EU

Commission’s Medical Device Regulations (EU MDR). The branded PLM SaaS solution focuses on

establishing a holistic PLM and QMS solution for product quality centered around a best practice

design control process.



The PLM & Quality solution comes pre-configured with best practices centered around a parts

centric approach to design control and product quality. The best practices were built upon ISO-

9001 and harmonized with ISO13485 2016. These pre-configured solutions were designed as a

baseline configuration for the customers final to-be workflows. They can be updated and

enhanced through configuration and can support certain levels of integration. A guidance

document can be provided so that configuration and customizations are forwards compatible

with future release of Windchill supported by PTC Cloud services.



1.2 WPQ Capabilities License Overview

The base solution includes the Windchill components listed below.

• Windchill Design Control

• eBOM Management

• Change Management

• Design Review

• Design History File (DHF)

• Device Master Record (DMR)

• MCAD Data Management – Creo (included), Solidworks, Inventor, AutoCAD

(additional)

• Windchill Document Control and Document Training

• Windchill Quality Management

• Customer Experience Management (CEM)/Complaints

• Corrective Action/Preventive Action

• Nonconformance

• Windchill Base Reporting

• Windchill Creo (multi-CAD) View Adapters

1.3 WPQ Capabilities by Roles

WPQ Core Capabilities View Contribute Author Find and view product information

Search indexed and non-indexed content

Define and execute user-specific saved searches (but not global searches) ✓ ✓ ✓

View any web page and web page content to which the viewer user is granted

authorization ✓ ✓ ✓

Download and view any office document content

Download any pre-published derived formats (PDF, IGES, STL)

Request publishing of derived formats on demand (for those supported)

Do not download any native CAD formats (MCAD, ECAD…)

✓ ✓ ✓

View reports created by others but cannot create or edit reports ✓ ✓ ✓



View thumbnails and 2-D and 3-D images

Pan, zoom, rotate, measure, section, explode

View but do not create/edit annotations

✓ ✓ ✓

Subscribe to be notified of events on items to which user has access ✓ ✓ ✓

Contribute, participate & collaborate

Create/edit folders

Create/edit links ✓ ✓

Workflow tasks

Project tasks

Action item tasks

✓ ✓

Create topics and discussion postings

Create and save annotations

Create/update action items

Create/attach/edit office documents (including use of Desktop Integration)

Create and update meetings

Participate in projects (does not include capability to create or manage projects,

plans, schedules, resources)

✓ ✓

Create/update problem reports ✓ ✓

Create deviation or waiver ✓ ✓

Create/attach/edit office documents (including use of Desktop Integration) ✓ ✓

Ability to have Document Control specific workflows: SOPs, Records Management,

SOP Training Related, Coversheet with watermarks ✓ ✓

Create/update Corrective and Preventative Actions process ✓ ✓

Create/update Complaints process ✓ ✓

Create/update Non-conformances process ✓ ✓

Electronic Signatures & CFR Part 11 Compliant Audit Trail ✓ ✓

Basic Authoring of content, and release and change management

Create and Manage Design History Files and Device Master Records ✓

Create Formal Design Reviews with audit trail and e-signatures ✓

Create and manage change objects of all types ✓

Create and manage collaboration project and plans ✓

Create and manage baselines ✓

Manage release process, set life cycle states, initiate workflow processes (such as

promotion requests) ✓

Manage templates and attributes (documents, parts, projects, teams, lifecycles,

workflows) ✓

Create and Manage global searches and reports ✓

Create and Manage Training Records ✓

Create and Manage Qualified Roles ✓

Create and manage projects, project teams and project content ✓

Create and manage project templates, team templates and project workflow

templates ✓

Create, execute and manage project plans with milestones, activities and tasks ✓

Create and manage project resources (people, equipment, facilities…) ✓

Create and manage action items, discussion forums and notebooks ✓

Create and manage project reports ✓

MCAD Data Management

Create and manage MCAD models using workgroup managers for all PTC-

supported CAD applications including Creo Parametric, Creo Direct, Creo

Elements/Direct, Creo Schematics, Creo Illustrator and Mathcad

✓

Create and manage MCAD models using workgroup managers for Solidworks,

Inventor and AutoCAD ✓

Automatically publish CAD formats with included Creo View CAD adapters for

Inventor and SolidWorks (native publishing is supported for Creo and AutoCAD) ✓

BOM Management



Automatically create and associate part BOM items with CAD documents on CAD

document check in ✓

Create and manage product structures and engineering BOMs ✓

Import BOM structure from Excel ✓

Create and manage product structure baselines ✓

Create and manage product instances ✓

Create and manage serialized products ✓

Transform a CAD BOM into a part BOM ✓

Intellectual Property Protection

Create and manage security labels and classifications and control access to

information based on user or group label or classification access level. ✓

Create and manage agreements (such as NDA, ITAR) and control access to

information based on the agreements that a user or group is covered to provide

access to agreement-controlled information.

✓

Manage agreement creation and change through workflow process ✓

Control which representations of content are available for view and download by

groups/roles and users. For example, some users may be given access to native

CAD formats and others will have only access to low-fidelity 2-D images or 3-D

viewable.

✓

An IP Protection add-on license is required for every user with access to a Windchill

system in order for a customer to use any IP protection functionality. User's with an

Author license can create and manage IP protection labels, agreements and

rules. All other users can view IP information for content to which they have view

access but cannot perform any of the IP Production management functions

above.

✓

1.4 WPQ Add-On Capabilities by Roles

WPQ Add-On Capabilities – Additional Charges View Contribute Author Manufacturing Process Management

Transform an engineering BOM to a Manufacturing BOM ✓

Create and manage manufacturing resources ✓

Create and manage process plans that use manufacturing resources ✓

Create and manage manufacturing BOMs ✓

Navigate

Use the capabilities of the Navigate Role based applications and ADK to view

Windchill data and custom applications for viewing information from PTC and non-

PTC systems.

Note: This license does not include support for building applications that create or

edit information in systems or connect to physical devices.

✓

Use the capabilities of the Navigate Role based applications and ADK to create

and edit Windchill data and custom applications from PTC and non-PTC systems.

Note: This license does not include support for building applications that create or

edit information in systems or connect to physical devices.

✓ ✓

Cloud Add-Ons – Additional Charges

Additional Environments

Additional Validation Services

Customizations & Integrations

Additional Storage

Single Sign-On

1.5 Partner Delivery

Partner solution configuration, development, and delivery is an important component of

customer success for the WPQ offering. When selecting a Partner for a WPQ solution, it is a



prerequisite that the Partner has expertise and experience delivering both Windchill and Quality

solutions. See the PTC web site for additional materials on the Partnership Network.

For additional information on Partner led PTC Cloud deployments see the PTC Cloud Service

Description Document.

1.6 Validation Ready Solution

For WPQ PLM SaaS, PTC partnered with USDM Life Sciences to provide customers with validation-

ready documentation (called the Validation Accelerator Pack (VAP)) for the pre-configured

best practice solution. After purchasing the solution, customers are provided with the

documents listed below by USDM. These documents provide the core for the base validation.

• System Requirements Specification Report- Admin & General

• Windchill Administrative and General Risk Assessment

• Windchill Med Cloud IOQ Summary Report

• Windchill Med Cloud Validation Plan

• Windchill Med Cloud Validation Summary Report

• Windchill Document Control VAP UAT

• Windchill Med Cloud Operational Qualification

• PTC Corporation Quality Audit Report

• Document Control

o System Requirements Specification Report-Document Control

o Windchill Document Control Traceability Matrix

o Windchill Document Control Risk Assessment Matrix

• Design Control

o System Requirements Specification Report-Design Control

o Windchill Design Control Traceability Matrix

o Windchill Design Control Risk Assessment Matrix

• Quality Management

o System Requirements Specification Report-NC, CAPA, Complaints

o Windchill NC, CAPA, Complaints Traceability Matrix

o Windchill NC, CAPA, Complaints Risk Assessment Matrix

Once solution development is completed, the USDM VAP documents can be utilized to jump-

start the changes to the requirements, traceability, IQ, and OQ documentation; along with,

supporting the customer’s Performance Qualification (PQ) and User Acceptance testing (UAT).

For all WPQ SaaS deliveries, the engagement of USDM will be initiated through our PTC Cloud

Service Management processes (see below).

PTC’s responsibility for the Validation of the customer’s system consists of standard evidence in

support of IQ and OQ that is provided to USDM as input to their VAP. Modifications to the

standard solution will require (as a pre-requisite) a written IQ and OQ plan with updated

evidentiary requirements.

2. Partner Delivery Process

2.1 Initial Delivery of the WPQ SaaS Instances

The initial delivery process starts after the customer completes the sale. During this process, PTC

Cloud is preparing the customer’s WPQ instances (development and production) and USDM is

completing their documentation.



The customer delivery timeframe will be confirmed by the PTC Cloud Service Management as

part of the sales closure process.

At the end of this process:

• The customer has access to the WPQ Cloud service.

• The validation document package has been delivered for the base solution.

• The customer/partner are ready to complete the development and configuration of the

solution.

Figure 1: Process steps from PO to URL delivered

2.2 Solution Development and Configuration

After the instances are installed and Service is available to the customer, the customer/partner is

ready to complete the solution configuration and development. During this phase, it is

important to keep track of the base solution changes to help identify which portions of the

solution requires additional validation. The PTC Cloud team will support build package and data

migrations for this phase. The changes and corresponding validation evidence is the customer’s

responsibility.

It is the customer’s/partner’s responsibility to keep track of changes (using a change

management process) and determine the level of re-validation required. The customer can

choose to complete the solution validation or have USDM participate in the process.

PTC Cloud Services will require Customer or USDM generated instructions for any deviations from

the standard evidence required to support IQ or OQ prior to executing any changes to the

delivered system. This includes changes to installed software components and the Windchill

PDMLink configuration.



There may be additional fees when making such modifications. This should be discussed

proactively with Cloud Service Management.

Figure 2: Process for configuring baseline solution

2.3 User Acceptance Testing

Once the solution and initial validation is completed (or an out-of-the-box solution is being used)

the solution is ready for User Acceptance Test (UAT). The UAT is completed by the customer

and/or partner.

After the UAT is completed, the customer notifies the PTC Cloud Service Manager to deploy the

solution into the Production environment.



Figure 3: UAT process flow



Sample Validation Project Plan

3. Post Production Changes

Once the customer is in Production, a Change Management process must be followed. There

are three types of changes that can be applied to the WPQ Service: System, Application and

Solution.

It is a joint PTC and customer responsibility to keep track of changes and ensure that an

appropriate change management process is followed. PTC will inform the customer of all PTC

initiated changes.

Note: There are some changes that typically do not require change management as long as it

does not modify the intended use of the application. An example of this type of change is data

input.

3.1 System Change

A System change is when the application operating environment is modified. Examples of

system changes include an upgrade to the operating system, Java version, or database version.

For each System change, PTC will work with USDM and evaluate the change to determine if it

modifies the intended use and requires additional validation. PTC will provide notification before

the change is made. Customers can utilize the notification to execute their own Change

Control process and determine if additional validation is required.

3.2 Application Changes

An Application change consists of the installation of a patch, minor release, or major upgrade

applied to the current version of the PTC Windchill application.

For a major functional release, a complete revalidation is typically required. A minor release

(containing issues resolution); the addition of new functionality; or changing existing functionality

usually requires some revalidation.

PTC and USDM will determine which specific versions of Windchill will be deemed Validation-

ready and will coordinate with the customer on when to execute an upgrade to their specific

environment(s).



For each Application change, PTC will work with USDM and evaluate the change to determine

the level of revalidation. Once implemented and tested, PTC and USDM will provide updated

validation documentation for the new standard solution.

Customers can utilize the updated documentation to execute their own Change Control

process and determine if additional validation is required. Customers will be required to provide

PTC with documentation that outlines their specific validation requirements to deploy their

solution to the upgraded version. There may be additional fees assessed to support the

additional validation beyond the standard offering. This should be discussed proactively with

Cloud Service Management.

3.3 Solution Changes

A Solution change is when a configuration or customization is modified and applied to the

current application version. Examples include new reports and queries, new workflows or

changes to existing workflows.

The addition of new fields or changing existing ones; if only through the core application,

typically require an update to the Configuration specification and change verification;

however, the usually do not require revalidation.

For each Solution change, Partners and Customers should execute their own Change Control

process and determine if additional validation is required. PTC will require that customers submit

a written explanation of Validation requirements when requesting PTC to propagate approved

solution changes to their production environment.

4. Extending WPQ PLM SaaS through PTC ThingWorx Navigate

WPQ PLM SaaS can be extended with ThingWorx Navigate to enhance and drive new positive

customer experiences. This can be purchased as an add-on to the existing solution and requires

a separate dedicated cloud environment. The USDM VAP does not currently include readiness

for Navigate and additional validation will be required.

MHarwood

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Windchill Product Quality SaaS Overview 1. Introduction · 2018-12-18 · Windchill Product Quality...

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