Computer Systems Validation
eBook - PDF

Computer Systems Validation

Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies

  1. 1,032 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

Computer Systems Validation

Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies

About this book

Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it is necessary to ensure that it is reliable, quality

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Yes, you can access Computer Systems Validation by Guy Wingate in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmacology. We have over one million books available in our catalogue for you to explore.

Information

Publisher
CRC Press
Year
2003
Print ISBN
9780849318719
eBook ISBN
9780203494240
Edition
1
Topic
Medicine
Subtopic
Pharmacology

Table of contents

  1. Front cover
  2. Foreword
  3. Preface
  4. The Editor
  5. Contributor Biographies
  6. Abbreviations
  7. Contents
  8. Chapter 1. Why Validate?
  9. Chapter 2. History of Computer Validation
  10. Chapter 3. Organization and Management
  11. Chapter 4. Supporting Processes
  12. Chapter 5. Prospective Validation Project Delivery
  13. Chapter 6. Project Initiation and Validation Determination
  14. Chapter 7. Requirements Capture and Supplier (Vendor) Selection
  15. Chapter 8. Design and Development
  16. Chapter 9. Coding, Configuration, and Build
  17. Chapter 10. Development Testing
  18. Chapter 11. User Qualification and Authorization to Use
  19. Chapter 12. Operation and Maintenance
  20. Chapter 13. Phaseout and Withdrawal
  21. Chapter 14. Validation Strategies
  22. Chapter 15. Electronic Records and Electronic Signatures
  23. Chapter 16. Regulatory Inspections
  24. Chapter 17. Capabilities, Measures, and Performance
  25. Chapter 18. Concluding Remarks
  26. Chapter 19. Case Study 1: Computerized Analytical Laboratory Studies
  27. Chapter 20. Case Study 2: Chromatography Data Systems
  28. Chapter 21. Case Study 3: Laboratory Information Management Systems (LIMS)
  29. Chapter 22. Case Study 4: Clinical Systems
  30. Chapter 23. Case Study 5: Control Instrumentation
  31. Chapter 24. Case Study 6: Programmable Logic Controllers
  32. Chapter 25. Case Study 7: Industrial Personal Computers
  33. Chapter 26. Case Study 8: Supervisory Control and Data Acquisition Systems
  34. Chapter 27. Case Study 9: Distributed Control Systems
  35. Chapter 28. Case Study 10: Electronic Batch Recording Systems (Manufacturing Execution Systems)
  36. Chapter 29. Case Study 11: Integrated Applications
  37. Chapter 30. Case Study 12: Building Management Systems
  38. Chapter 31. Case Study 13: Engineering Management Systems
  39. Chapter 32. Case Study 14: Spreadsheets
  40. Chapter 33. Case Study 15: Databases
  41. Chapter 34. Case Study 16: Electronic Document Management Systems (EDMS)
  42. Chapter 35. Case Study 17: MRP II Systems
  43. Chapter 36. Case Study 18: Marketing and Supply Applications
  44. Chapter 37. Case Study 19: IT Infrastructure and Associated Services
  45. Chapter 38. Case Study 20: Local and Wide Area Networks
  46. Chapter 39. Case Study 21: Web Applications
  47. Chapter 40. Case Study 22: Medical Devices and Their Automated Manufacture
  48. Chapter 41. Case Study 23: Blood Establishment Computer Systems
  49. Chapter 42. Case Study 24: Process Analytical Technology
  50. Glossary
  51. Index
  52. Back cover