Electronic Systems What should the QP consider?

QP Forum April 2015 Dr. Lorraine Brophy – QA Manager/QP Janssen Biologics Ireland

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Agenda

• Data Integrity (DI) Overview

• Overview of Janssen Biologics (JBIL) Electronic Systems

• How did we get here?

• How have Electronic Systems changed our Environment?

• What the QP interaction looks like now?

• Considerations for moving to Electronic Systems

• What does the future hold?

• Ensuring Sustained Compliance – DI Risk evaluation

• Conclusion

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What is Data Integrity

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• Data Integrity can be defined as the degree at which a collection of data is complete, consistent and accurate throughout the Data Lifecycle (Regulatory Agency Guidance).

• Good data integrity is ensuring the design our data records and data management systems ensure all details are accurately captured such that Batch Release decision's can be made and verified.

•“All phases in the life of the data (including raw data) from initial generation and recording through processing (including transformation or migration), use, data retention, archive / retrieval and destruction” (Regulatory Agency Guidance).

What is Data Lifecycle?

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Overview of Janssen Electronic Systems – Where we are now?

LIMS

Sample planning & scheduling

Sample info & test limits to

LES

Final batch disposition to

SAP

Generate CoA

LES

Method Execution

Instrument data capture

Review by exception

Final results to LIMS

Instrumentation / Reagents

e.g. Empower; Instrument Calibration

Consumable Inventory Management System

SAP

SDMS

Analyst Layer

Supervisor Layer

= Interfaces

MES

Empower

Laboratory System Integration– Where we are now?

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How did we get here?

1. MBR Design

2. Change Management

A change in culture and training required to ensure there is correct and appropriate understanding of Data, Meta Data, system interfaces and Risks

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How did we get here?

3. Quality Risk Management

The output of a risk assessment is a quantitative estimate of risk or a qualitative description of a range of risk to using Electronic systems in a Lab and Manufacturing Environment There are three fundamental questions for clearly defining the risk: • What might go wrong? Consider what is known or predictable. • Can it be detected and at what level? • What is the probability (likelihood) it will go wrong? (severity)?

4. CPV

Data obtained from routine production is used to provide ongoing assurance that the process remains in the state of control

5. Equipment Standardization

Global alignment is Key to the Automation Roadmap at Janssen, a standardized approach, global interaction on changes and systems designed with the needs of all impacted sites for optimal operability

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• Autoclosure is the functionality in MES where executed Equipment Specification (ESP), Buffer and Media batch records are closed by the system once certain criteria are met

• Process applied Risk Evaluation (FMEA) to Identify system limitations and design controls to ensure automated rules for closure of Batch records.

Autoclosure

• Review by Exception is the process by which defined batch records can be assigned a reviewed status based on an assessment of the exceptions generated

• Process applied Risk Evaluation (FMEA) to Identify all parameters which have been proven to be correctly evaluated by the system whereby the MBR design is such that any procedural deviations will generate an exception of the required criticality level

Review by Exception

How have Electronic Systems changed our Environment?

These processes facilitate a more efficient review process which is designed to flag discrepancies, prevent data manipulation and ensure a consistent data review process.

BENEFITS

Equipment State Diagrams(clean/ available/ SIP’d) enforced fields Enforced Consumptions for BOM items Flags designed to stop MBR/create exception if Recipe Controlling Automation is suspended, if expired material is scanned.

What do QP Interactions look like now?

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Front End Compliance

Batch Review

Ongoing

Compliance

• Internal Audit Program

• Change Control Process

• Quality Management Review

• Quality Risk Management

• QP attend all MBR interactive reviews to ensure CPP design and compliance with Product Licence.

• QP’s approve implementation of changes ensuring appropriate justification and consideration is applied to Critical Data.

• QP can review Batch Records in the Source system

• Batch Execution exceptions are flagged and highlighted

• CPP report available for review

• CPV trends can be added to the electronic systems

Quality System Oversight

Optimized Review Process

Points to consider when introducing Electronic Systems

• Importance of raw data

• Audit trails

• Security access

• Reviewing in source system

• Knowledge of interfaces

• Periodic review of Data Retention/ Retrieval / Archiving

• System limitations

• Output required from the systems

• CSV support

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What does the future hold?

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• Controlled output • APR • CPV • Metrics

•Data management •Data Access in Real Time •Real time Analysis Results

Mobile Technology

• Change in culture and understanding of the Data Generated must be built into training processes

• Intentionally designed resource model

Competency of People

• Design to consider the next interface planned!

• Consider all the inputs and outputs to electronic systems

Systems designed to be fit for purpose

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How can we Ensure Sustained Compliance

• To Understand the Risks to the Business , Initiate Risk Assessment s for Laboratory Systems and Execution systems considering the flow of data

• Categorise Risks in terms on compliance

• Develop appropriate remediation strategy based on Risk Categorisation

• Implement Assessments through Internal Audit program at a site Level

• Implement Assessments for Contract Laboratories through Supplier Qualification Process

Risk Understanding

Program

Design

Framework for Data Integrity Assessment Program

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Framework for Data Integrity Assessment Program

Internal / External Security

• Access Limitations

• Audit Trail

• Date/ Time

Source Documentation

• Electronic record is the Source Data

• Data migration Processes

Data Management

• Direct entry

• Data Retrieval

• System Control

• Change controls

• Training

General

- Quality

Systems

Validation of

systems

- Annex 11 & CFR part 11

Assessments

- Processes and Procedure's

- Metric driven behaviours

A standardized tool was developed for the Site Program based on Regulatory Agency Guidance & Recent Industry focus Areas

Conclusion

• Design and control √

– Knowledge of interfaces

• Data integrity and security √

• Change Management √

• People Competency √

• Continuous improvement √

• Ongoing Compliance √

• Inputs Vs Outputs √

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