Pharmaceutical Computer Systems Validation
eBook - PDF

Pharmaceutical Computer Systems Validation

Quality Assurance, Risk Management and Regulatory Compliance

  1. 773 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

Pharmaceutical Computer Systems Validation

Quality Assurance, Risk Management and Regulatory Compliance

About this book

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.

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Information

Publisher
CRC Press
Year
2016
Print ISBN
9781420088946
eBook ISBN
9781420088953
Edition
2
Topic
Medicine
Subtopic
Pharmacology

Table of contents

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

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