Pharmaceutical computer systems validation quality assurance, risk management and regulatory compliance

✍ Scribed by Wingate, Guy(Editor)

• Publisher: Informa Medical
• Year: 2010;2016
• Tongue: English
• Leaves: 773
• Edition: Second edition
• Category: Library

✦ Synopsis

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

✦ Table of Contents

Foreword to the Second Edition......Page 8
Foreword to the First Edition......Page 9
Preface......Page 12
Contributor Biographies......Page 14
Abbreviations......Page 21
Contents......Page 30
Chapter 1. Introduction......Page 34
Chapter 2. Organization and Management......Page 51
Chapter 3. Supporting Processes......Page 65
Chapter 4. Prospective Verification and Validation......Page 88
Chapter 5. Project Initiation and Compliance Determination......Page 114
Chapter 6. Requirements Capture and Supplier (Vendor)Selection......Page 136
Chapter 7. Design and Development......Page 161
Chapter 8. Coding, Configuration, and Build......Page 187
Chapter 9. Development Testing......Page 200
Chapter 10. User Qualification and Authorization to Use......Page 211
Chapter 11. Operation and Maintenance......Page 236
Chapter 12. Phaseout and Withdrawal......Page 269
Chapter 13. Electronic Records and Electronic Signatures......Page 281
Chapter 14. Regulatory Inspections......Page 309
Chapter 15. Compliance Strategies......Page 342
Chapter 16. Capabilities, Measures, and Performance......Page 369
Chapter 17. Practical Troubleshooting......Page 389
Chapter 18. Concluding Remarks......Page 395
Chapter 19. Case Study 1: Computerized Analytical Laboratory Systems......Page 401
Chapter 20. Case Study 2: Chromatography Data Systems......Page 415
Chapter 21. Case Study 3: Laboratory Information Management Systems......Page 439
Chapter 22. Case Study 4: Clinical Systems......Page 467
Chapter 23. Case Study 5: Control and Monitoring Instrumentation......Page 482
Chapter 24. Case Study 6: Process Control Systems......Page 512
Chapter 25. Case Study 7: Manufacturing Execution Systems and Electronic Batch Records......Page 532
Chapter 26. Case Study 8: Building Management Systems......Page 548
Chapter 27. Case Study 9: Engineering Management Systems......Page 568
Chapter 28. Case Study 10: Desktop Applications Including Spreadsheets......Page 589
Chapter 29. Case Study 11: Databases......Page 601
Chapter 30. Case Study 12: Electronic Document Management Systems......Page 615
Chapter 31. Case Study 13: Enterprise Resource Planning Systems......Page 629
Chapter 32. Case Study 14: Marketing and Supply Applications......Page 648
Chapter 33. Case Study 15: IT Infrastructure and Associated Services......Page 683
Chapter 34. Case Study 16: Internet/Intranet Applications......Page 710
Chapter 35. Case Study 17: Medical Devices and Their Automated Manufacture......Page 722
Chapter 36. Case Study 18: Blood Establishment Computer Systems......Page 736
Chapter 37. Case Study 19: Process Analytical Technology......Page 749
Chapter 38. Case Study 20: Computer Applications Supporting the Supply of Biotechnology Products......Page 759
Glossary......Page 762