Computer Systems Validation
eBook - ePub

Computer Systems Validation

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

  1. 1,032 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

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 & Chemistry. 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
9781135496319
Topic
Medicine
Subtopic
Chemistry
Index
Chemistry

Table of contents

  1. Cover
  2. Half Title
  3. Title Page
  4. Copyright Page
  5. Dedication Page
  6. Frontmatter
  7. Foreword
  8. Preface
  9. The Editor
  10. Contributor Biographies
  11. Abbreviations
  12. Table of Contents
  13. 1 Why Validate?
  14. 2 History of Computer Validation
  15. 3 Organization and Management
  16. 4 Supporting Processes
  17. 5 Prospective Validation Project Delivery
  18. 6 Project Initiation and Validation Determination
  19. 7 Requirements Capture and Supplier (Vendor) Selection
  20. 8 Design and Development
  21. 9 Coding, Configuration, and Build
  22. 10 Development Testing
  23. 11 User Qualification and Authorization to Use
  24. 12 Operation and Maintenance
  25. 13 Phaseout and Withdrawal
  26. 14 Validation Strategies
  27. 15 Electronic Records and Electronic Signatures
  28. 16 Regulatory Inspections
  29. 17 Capabilities, Measures, and Performance
  30. 18 Concluding Remarks
  31. 19 Computer Systems Validation
  32. 20 Case Study 2: Chromatography
  33. 21 Case Study 3: Laboratory Information Management Systems (LIMS)
  34. 22 Case Study 4: Clinical Systems
  35. 23 Case Study 5: Control Instrumentation
  36. 24 Case Study 6: Programmable
  37. 25 Case Study 7: Industrial Personal Computers
  38. 26 Case Study 8: Supervisory Control and Data Acquisition
  39. 27 Case Study 9: Distributed
  40. 28 Case Study 10: Electronic Batch Recording Systems (Manufacturing Execution
  41. 29 Case Study 11: Integrated
  42. 30 Case Study 12: Building
  43. 31 Case Study 13: Engineering
  44. 32 Case Study 14: Spreadsheets
  45. 33 Case Study 15: Databases
  46. 34 Case Study 16: Electronic
  47. 35 Case Study 17: MRP II Systems
  48. 36 Case Study 18: Marketing and
  49. 37 Case Study 19: IT Infrastructure and Associated Services
  50. 38 Case Study 20: Local and Wide Area Networks
  51. 39 Case Study 21: Web Applications
  52. 40 Case Study 22: Medical Devices and Their Automated Manufacture
  53. 41 Case Study 23: Blood Establishment Computer Systems
  54. 42 Case Study 24: Process Analytical Technology
  55. Glossary