New GAMP Data Integrity Good Practice Guidance and ...

1 New gamp Data Integrity good Practice Guidance and Experience from the Field Speakers Sion Wyn Paul Moody Director, Conformity Ltd. Director, Supplier Quality, Alexion Pharmaceuticals, Inc. Sion Wyn is a well-known and internationally acknowledged specialist in computer systems Paul is a well-known and respected specialist in life- validation and compliance and life-science science regulations. He (ex HPRA) has over 20. regulations in this field. He is the Editor of the ISPE years' experience within the pharmaceutical and gamp 5 guide : A Risk-Based Approach to medical device sectors with expertise in the area of Compliant GxP Computerized Systems and received pharmaceutical regulation including data Integrity .

2 The 2006 ISPE Professional Achievement Award for his work. Sion assisted the US Food and Drug Administration (FDA) as a consultant with its re-examination of the 21 CFR Part 11 regulation on electronic records and signatures and was a member of the core team that produced the FDA Guidance on 21 CFR Part 11. Scope and Application. Connecting Pharmaceutical Knowledge 2. New gamp Data Integrity good Practice Guidance Sion Wyn Director, Conformity Ltd Overview Background and context - ISPE gamp Guidance on DI. Update on published and planned Guidance Some highlights and selected topics Connecting Pharmaceutical Knowledge 4.

3 gamp guide : Records &. Data Integrity Published March 2017. Stand-alone guide , aligned to gamp 5. Connecting Pharmaceutical Knowledge 5. Translations ISPE gamp Leitfaden zur ISPE gamp Japanese translation Aufzeichnungs-und published October 2018. Datenintegrit t . Connecting Pharmaceutical Knowledge 6. Objective to encourage innovation and technological advance while avoiding unacceptable risk to product quality, patient safety, and public health technological advance can improve data Integrity and promote better use of data for the benefit of the patient and the public Connecting Pharmaceutical Knowledge 7.

4 Key Concepts Connecting Pharmaceutical Knowledge 13. Risk Management Approach Application of appropriate controls to manage identified risks within the context of the regulated process Effort required to assess and manage risk should be commensurate to the level of risk Requires a full understanding of the regulated process to be supported, including the intended use of data within the process Applying gamp 5 Quality Risk Management, following ICH Q9 . 9 Connecting Pharmaceutical Knowledge 14. Governance Governance topics including: Leadership Culture Human Factors Roles and Responsibilities Policies, Standards, and Procedures Maturity Connecting Pharmaceutical Knowledge 10.

5 Maturity Model Process Areas define the areas to be assessed, and for each area defines the Maturity Factors to be assessed against Maturity Level Characterization gives examples of possible or typical states related to the levels Example Example Maturity Example Process Area Factor Maturity Level Characterizations Level 1 Level 2 Level 3 Level 4 Level 5. Data Clear ownership of Process, Process, Process, Process, Process, Ownership data and data- system, and system, system, and system, and system, related data owners and data data owners data owners and data responsibilities not defined owners typically are well owner identified defined in defined and responsibili in few many, but documented.

6 Ties areas. not all cases, considered and and responsibiliti clarified es not during always clear manageme nt review. Connecting Pharmaceutical Knowledge 11. Data Life Cycle 12 Connecting Pharmaceutical Knowledge 26. gamp Data Integrity Guidance Topics also in development include: DI for medical devices Data life cycle including archival and retention DI for clinical systems 2018 2019. 2017. Just Published! And Japanese translation . Connecting Pharmaceutical Knowledge 13. Data Integrity GPG - Key Concepts Further good Practice Guidance in four core areas: Data Governance Data Life Cycle Risk Management Approaches Critical Thinking Supplemented by appendices: checklists, examples and case studies Connecting Pharmaceutical Knowledge 14.

7 Selected Topics and Highlights . Culture and Leadership Aligned with the ISPE Cultural Excellence Report (April 2017). Interfaces Building on approaches and principles from gamp 5. and the gamp Record and Data Integrity guide Tools, Checklists, and Examples Building on gamp 5, the gamp Record and Data Integrity guide , and the Cultural Excellence Report Connecting Pharmaceutical Knowledge 15. ISPE Cultural Excellence Report Six Dimensions of Cultural Excellence A move away from the traditional culture of compliance' towards a culture of excellence'. a shift from reliance solely on regulatory compliance to an emphasis on continuous improvement in which there is deep understanding throughout an organization of the elements critical to product quality.

8 Culture and Organizational Maturity . Connecting Pharmaceutical Knowledge System Interfaces Often custom ( gamp Category 5) software components Requiring a well-planned specification, design, and verification process Sample Structure of an Interface Requirements Specification Interface Requirements Specification Section Description xxx xxx yyy yyy Typical Data Integrity Issues Related to Data Interfaces Risk / Lack / Issue Possible Causes Possible Mitigations or Controls xxx xxx xxx yyy yyy yyy Connecting Pharmaceutical Knowledge 17. Tools, Checklists, and Examples Data Integrity Gemba Checklist for the Lab IMPACT* Tool Applied to Data Integrity *IMPACT: Identify goal, select the Measure, Pinpoint the behaviour, Activate the Case Study Example Systems Consequences, Transfer knowledge.

9 Clinical Trials, Medical Device Manufacture, Laboratory, Spreadsheet, Process Control, Business Application Process and Data Mapping examples Use Cases, Flow Diagrams, Data Modelling, Data Flow Diagrams Example Data Classification System Connecting Pharmaceutical Knowledge 18. Selected Topics and Highlights Terminology (including Data Audit Trails). Aligned with, and expanding on, the gamp Record and Data Integrity guide , as well as existing PCS and MES. GPGs Data Flows and Data Lifecycles Building on approaches and principles from gamp 5, existing gamp GPGs, and the gamp Record and Data Integrity guide Detecting and Managing DI Risks Building on gamp 5, the gamp Record and Data Integrity guide , and The gamp DI Key Concepts GPG.

10 Connecting Pharmaceutical Knowledge 19. Connecting Pharmaceutical Knowledge 20. Recap gamp Data Integrity Guidance Topics also in development include: DI for medical devices Data life cycle including archival and retention DI for clinical systems 2018 2019. 2017. Just Published! And Japanese translation . Connecting Pharmaceutical Knowledge 21. What gamp Continues to Aim For! Pragmatic interpretation of regulatory requirements Identification and definition of real-world good Practice Support for new and innovative technologies #1. Connecting Pharmaceutical Knowledge 22.