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Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance book cover

2nd Edition

Pharmaceutical Computer Systems Validation Quality Assurance, Risk Management and Regulatory Compliance

Edited By Guy Wingate Copyright 2010
    798 Pages 320 B/W Illustrations
    by CRC Press

    Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

    Key topics in Pharmaceutical Computer Systems Validation, Second Edition include:

    • GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008
    • ICH Guidance Q8, Q9, and Q10 expectations
    • FDA cGMPs for the 21st Century Initiative and associated guidance
    • PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments
    • WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
    • the indirect developments from FDA/EU/Japan regulators and industry
    • the role of QA department, and internal and external suppliers
    • the integration of computer systems validation into single overall approach for wider system
    • practical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer system
    • managing outsource partners and handling legacy systems
    • topical issues uncovered by regulatory authorities including US FDA

    Foreword to the Second Edition, Foreword to the First Edition, Preface, Contributor Biographies, Abbreviations, Contributors, 1. Introduction, 2. Organization and Management, 3. Supporting Processes, 4. Prospective Verification and Validation, 5. Project Initiation and Compliance Determination, 6. Requirements Capture and Supplier (Vendor) Selection, 7. Design and Development, 8. Coding, Configuration, and Build, 9. Development Testing, 10. User Qualification and Authorization to Use, 11. Operation and Maintenance, 12. Phaseout and Withdrawal, 13. Electronic Records and Electronic Signatures, 14. Regulatory Inspections, 15. Compliance Strategies, 16. Capabilities, Measures, and Performance, 17. Practical Troubleshooting, 18. Concluding Remarks, 19. Case Study 1: Computerized Analytical Laboratory Systems, 20. Case Study 2: Chromatography Data Systems, 21. Case Study 3: Laboratory Information Management Systems, 22. Case Study 4: Clinical Systems, 23. Case Study 5: Control and Monitoring Instrumentation, 24. Case Study 6: Process Control Systems, 25. Case Study 7: Manufacturing Execution Systems and Electronic Batch Records, 26. Case Study 8: Building Management Systems, 27. Case Study 9: Engineering Management Systems, 28. Case Study 10: Desktop Applications Including Spreadsheets, 29. Case Study 11: Databases, 30. Case Study 12: Electronic Document Management Systems, 31. Case Study 13: Enterprise Resource Planning Systems, 32. Case Study 14: Marketing and Supply Applications, 33. Case Study 15: IT Infrastructure and Associated Services, 34. Case Study 16: Internet/Intranet Applications, 35. Case Study 17: Medical Devices and Their Automated Manufacture, 36. Case Study 18: Blood Establishment Computer Systems, 37. Case Study 19: Process Analytical Technology, 38. Case Study 20: Computer Applications Supporting the Supply of Biotechnology Products, Glossary, Index

    Biography

    Guy Wingate

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