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WorkshopMES & Data IntegrityPharmaTalk 2017

Ella SchauerHGP Deutschland

Thomas HalfmannHalfmann Goetsch Partner AG

Berlin, 9 June 2017

Healthcare Industry Partners

2

MES & Data Integrity Workshop

• Data Integrity considerations for Electronic Batch Records

• What do the regulators expect?

• MES validation & data integrity considerations

• Technical and architecture considerations

• Records life cycle considerations (retention, archiving, migration)

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What Describes MES in Pharmaceutical Manufacturing?

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IT system that manage manufacturing operations

track and document the transformation of raw materials to finished goods

works in real time

management of resources (personnel , machines, work centers, services, …)

collection of production data and information, e.g. equipment status information, process data, … and creates an "as-built" record (Electronic Batch Record)

Manufacturing Operations Architecture

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Level 4Business Control

Level 3Plant Control

Level 2 / 1Machine Control

ERP

MES (EBR)

AutomationSCADA / DCS / PCS

Manufacturing Automation Architecture ConsiderationsMES is not alone!

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Learning Management

Advanced Planning

SOP Management EQMS

Time Management

Labeling

Reporting

ERP

Material Management

PreventiveMaintenance

Finance & Controlling

Inventory Management

Production Planning

MESWeighing

DispensingMaterial Tracking

Recipe / MBRManagement

Batch Execution

Performance Management

Building Management

Warehouse Control System

Process Automation

LIMS

PAT

Master DataManagement

Is Data Integrity a Real Concern?This Really Happens…

Since 2013 data integrity received increasing attention by regulators due to data integrity deficiencies found in inspection, like:

• Review of audit trails

• Access controls to electronic systems

• Data back-up

• Supplier quality management

• Failure to include complete data

• Audit trail, data control, and sharing password

• …

Regulators will assume that non-compliance or faulty data is intentional and not accidental!

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• Data integrity requirements are in place for many years

• No change in basic requirements

A ttributable

L egible

C ontemporaneously recorded

O riginal or a true copy

A currate

+ complete, consistent and enduring

Why Is Data Integrity Still a Concern?

Nothing new:

• ”… entries made in clear indelible handwriting...”

• “... alterations ... signed and dated ... permit reading of original ... reason recorded”

• “... records completed at the time each action taken ...”

• “... accuracy of records should be checked ...”

• “... name of person carrying out activities ...”

EU GMP Guideline (1989)

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MES as Enabler of Data Integrity

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Q: Electronic Batch Records & Data Integrity

• With (most) MES solutions, the concept of “Review by Exception” is implemented. How is this concept impacted in context of data integrity?

can we trust the data in the Electronic Batch Record?

data is collected during operations. What needs to be considered for technical integration, i.e. collecting data via a technical interface direct from the data source?What needs to be considered for a non-technical integration, i.e. operators entering the data into MES?

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Manufacturing Automation Architecture ConsiderationsMES is not alone!

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Learning Management

Advanced Planning

SOP Management EQMS

Time Management

Labeling

Reporting

ERP

Material Management

PreventiveMaintenance

Finance & Controlling

Inventory Management

Production Planning

MESWeighing

DispensingMaterial Tracking

Recipe / MBRManagement

Batch Execution

Performance Management

Building Management

Warehouse Control System

Process Automation

LIMS

PAT

Master DataManagement

MES & Data Integrity

• MES provides data and information for product release, i.e. critical decisions are made based upon these information

• Information used for critical decisions must be trustworthy:

How is the data generated, processed, verified?

Is it ensured that data is not altered without traceability of the alterations?

Is it possible to trace back all manufacturing related data and information? Can we rebuild the whole story?

• To understand and trust the information of an EBR, we need to understand

the data source

the data flow (interfaced systems and operator interactions)

the data ownership

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MES collects production data and information, e.g. equipment status information, process data, … and creates an "as-built" record (Electronic Batch Record) that is used to confirm production of medicinal products according to cGMP regulation and therefore provides the information for product and batch release.

Data Integrity Success Factors

• Human Factors

Data Integrity Awareness

Data Integrity Training Program

MES Advisory & Governance Team (interdisciplinary team from operations, QA, IT, engineering, logistics) to facilitate continuous improvement and learning management)

• Data Integrity Maturity Model

Record identification and ownership

Providing a Data Integrity maturity framework

Data Integrity maturity assessment (MES DI checklist, multi-system / multi-function assessment tool, …)

Inspection Readiness

• Data Integrity Operations

Audit Trail Reviews

Data Integrity design (user requirements, interface design, system architecture, …)

Records life cycle considerations (retention, archiving, migration)

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What Do The Regulators Expect?European Medicines Agency (EMA)

“Data integrity enables good decision-making by pharmaceutical manufacturers and regulatory authorities. It is a fundamental requirement of the pharmaceutical quality system described in EU GMP chapter 1, applying equally to manual (paper) and electronic systems.”

“Computerised systems should be designed in a way that ensures compliance with the principles of data integrity. The system design should make provisions such that original data cannot be deleted and for the retention of audit trails reflecting changes made to original data.”

“Exception Reporting is used commonly as a tool to focus the review of electronic data such as (but not limited to) electronic batch records. Exception reporting rapidly highlights to the reviewer one of the most critical elements of batch review, i.e. the exceptions. The level of review of the full electronic batch record can vary based on the exceptions as well as the level of confidence and experience with a particular process. Appropriate testing and validation must be completed for the automated system and the output Batch Exception Report to ensure its functionality meets the business and regulatory requirements as per GMP.”

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MES & Data IntegrityDesign Considerations

What do you consider in regards of data integrity when specifying MES requirements?

Architecture considerations to be done during design:

• Records & data management

• Database architecture

• Access management & system security

• System inventory

• Interface design

• Life cycle management

• Data ownership

• …

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Data Integrity endangered by Integration

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DefinitionStandardizationHarmonization

AggregationConversion

Consolidation

Integration of DataData Integrity

MES Architecture & Data Integrity ConsiderationsData Ownership

• Data ownership?

What system is the leading system for master data, inventory data, equipment data, process data, …

How are architecture, system design and intefraces impacted in context of data integrity?

• Data relationship?

E.g.: MES is “batch driven”, LIMS is “sample driven” – samples from manufacturing operations need to be assigned to specific batches

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21st Century Manufacturing IT and Automation SolutionsWhat is the shop floor of the future? How is DI impacted?

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Pharmaceutical business models and pharmaceutical manufacturing will change!• Continuous manufacturing• Personalized medicine• End-to-end supply chain visibility• …

System architectures will change!• Highly integrated systems architecture• Cloud solutions• Industrial Internet of Things (IIoT) /

Industry 4.0• …

MES / MOM as a concept will be needed!• process control & integration• user guidance• compliance enforcement

GAMP Good Practice GuideRecords and Data Integrity

• Corporate Data Integrity Program

• Data Integrity Maturity Model

• Human Factors

• Data Audit Trail and Audit Rail Review

• Data Auditing and Periodic Review

• Inspection Readiness

• Integrating Data Integrity Into Existing Records Management Process

• User Requirements

• Process Mapping and Interfaces

• Risk Control Measures for Records, Data, and Electronic Signatures

• Data Integrity Concerns Related to System Architecture

• Data Integrity for End User Applications

• Retention, Archiving, and Migration

• Paper Records and Hybrid Situations

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Conclusions

• Data Integrity is a concern for MES

• Data integrity must be built into the process, system and architecture design

• It is important to understand and trust the information of an EBR, including

data source

data flow (interfaced systems and operator interactions)

data ownership

Data Integrity Maturity Assessment

• Do not forget the human factor

Data Integrity Awareness & Training

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Contact

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HGP Deutschland GmbHTheodor-Heuss-Allee 112D-60486 FrankfurtDeutschland

T +49 69 667741 343

E deutschland@hgp.agI www.hgp.ag

Ella Schauer Key Account ManagerSenior Consultant

E ella.schauer@hgp.agT +49 69 667741 343

Contact

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Thomas Halfmann Partner

E thomas.halfmann@hgp.agT +41 61 544 00 01

Halfmann Goetsch Partner AGSt. Alban-Vorstadt 944052 BaselSwitzerland

T +41 61 544 00 00

E info@hgp.agI www.hgp.ag

Records life cycle considerations (retention, archiving, migration)

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MES MigrationData Migration Considerations

Data to be Migrated Potential Risks

Master data • Depending on master data system…• If master data is managed by ERP or external master data system, no risk associated

with MES migration• If master data is (also) managed by MES, either master data may be migrated on

data base level or requires manual re-keying

Inventory data • If ERP is the leading system for inventory management, no to low risk• If MES is managing inventory, it might require re-keying of inventory data

Equipment statuses • Most likely, all equipment status must be re-entered into new system

Master batch records • Automatic migration of master batch records is most likely not possible or has a huge impact on data integrity

• All master batch records must be reviewed, updated and re-entered into the new MES

Historic data • Archiving is an option, however how do we access historic batch data whilst maintaining all data relations

• Transferring historic data into the new system might not be not possible (i.e. in case of new vendor or new platform by same vendor)

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