Electronic Systems. What should the QP consider? QP Forum April Dr. Lorraine Brophy QA Manager/QP Janssen Biologics Ireland

Transcription

1 Electronic Systems What should the QP consider? QP Forum April 2015 Dr. Lorraine Brophy QA Manager/QP Janssen Biologics Ireland

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5 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 4

6 What is Data Integrity 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. What is Data Lifecycle? 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). 5

7 Overview of Janssen Electronic Systems Where we are now? 6

8 Laboratory System Integration Where we are now? SAP MES LIMS Empower Supervisor Layer SDMS Sample planning & scheduling LES Analyst Layer Sample info & test limits to LES Final batch disposition to SAP Generate CoA Method Execution Instrument data capture Review by exception Final results to LIMS Instrumentation / Reagents e.g. Empower; Instrument Calibration Consumable Inventory Management System = Interfaces

9 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 8

10 3. Quality Risk Management How did we get here? 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 9

11 How have Electronic Systems changed our Environment? Autoclosure Review by Exception 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. 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 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. BENEFITS These processes facilitate a more efficient review process which is designed to flag discrepancies, prevent data manipulation and ensure a consistent data review process. 10

12 What do QP Interactions look like now? Front End Compliance 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. Ongoing Compliance Internal Audit Program Change Control Process Quality Management Review Quality Risk Management Quality System Oversight Batch Review 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 Optimized Review Process 11

13 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 12

14 Mobile Technology What does the future hold? Data management Data Access in Real Time Real time Analysis Results Controlled output APR CPV Metrics Competency of People Change in culture and understanding of the Data Generated must be built into training processes Intentionally designed resource model Systems designed to be fit for purpose Design to consider the next interface planned! Consider all the inputs and outputs to electronic systems 13

15 How can we Ensure Sustained Compliance Risk Understanding 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 Framework for Data Integrity Assessment Program Program Design 14

16 Framework for Data Integrity Assessment Program General 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 - Quality Systems Validation of systems - Annex 11 & CFR part 11 Assessments - Processes and Procedure's A standardized tool was developed for the Site Program based on Regulatory Agency Guidance & Recent Industry focus Areas - Metric driven behaviours 15

17 Conclusion Design and control Knowledge of interfaces Data integrity and security Change Management People Competency Continuous improvement Ongoing Compliance Inputs Vs Outputs 16

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