Pharmaceutical Computer Systems Validation
Quality Assurance, Risk Management and Regulatory Compliance
2nd Edition
Published on 23. February 2010
Book
Hardback
798 pages
978-1-4200-8894-6 (ISBN)
Description
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
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
More details
Edition
2nd edition
Language
English
Place of publication
Bosa Roca
United States
Publishing group
Taylor & Francis Inc
Target group
Professional and scholarly
Academic and Professional Practice & Development
Illustrations
320 s/w Abbildungen
320 Illustrations, black and white
Dimensions
Height: 260 mm
Width: 183 mm
Thickness: 47 mm
Weight
1667 gr
ISBN-13
978-1-4200-8894-6 (9781420088946)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
New editions
Guy Wingate
Pharmaceutical Computer Systems Validation
Volume 1 - Quality Assurance, Risk Management and Regulatory Compliance
Book
approx. 06/2026
3rd Edition
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€234.50
Not yet published
Additional editions
Guy Wingate
Pharmaceutical Computer Systems Validation
Quality Assurance, Risk Management and Regulatory Compliance
Book
10/2024
2nd Edition
CRC Press
€75.70
Shipment within 10-20 days
Guy Wingate
Pharmaceutical Computer Systems Validation
Quality Assurance, Risk Management and Regulatory Compliance
E-Book
04/2016
2nd Edition
CRC Press
€62.99
Available for download
Guy Wingate
Pharmaceutical Computer Systems Validation
Quality Assurance, Risk Management and Regulatory Compliance
E-Book
04/2016
2nd Edition
CRC Press
€63.49
Available for download
Person
Guy Wingate
Content
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