Pharmaceutical Computer Systems Validation
Quality Assurance, Risk Management and Regulatory Compliance
2nd Edition
Published on 19. April 2016
798 pages
978-1-4200-8895-3 (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.
More details
Edition
2nd edition
Language
English
Place of publication
Baton Rouge
United States
Publishing group
Taylor & Francis Inc
Target group
Professional and scholarly
Control engineers, laboratory technicians, IT professionals and management in pharmaceutical and healthcare companies; engineering contractor companies; analytical equipment suppliers; computers systems and software suppliers; and consultants.
Edition type
Revised edition
Illustrations
320 s/w Abbildungen
320 b/w images
File size
10,44 MB
ISBN-13
978-1-4200-8895-3 (9781420088953)
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
E-Book
approx. 06/2026
3rd Edition
CRC Press
€251.99
Available for download
E-Book
approx. 06/2026
3rd Edition
CRC Press
€250.99
Available for download
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
Book
02/2010
2nd Edition
CRC Press
€271.50
Shipment within 15-20 days
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
