Skip to content
GXP International
  • Home
  • CSV Articles
  • Publications
  • Book Store
  • CSV Blog
  • About Teri Stokes
  • Chat Note to Teri
GXP International
  • Home
  • CSV Articles
  • Publications
  • Book Store
  • CSV Blog
  • About Teri Stokes
  • Chat Note to Teri

06. Blue Book History

06. Historical Perspective on Computer Validation – FDA’s 1983 Blue Book

By Teri Stokes | April 6, 2012

The questions that the Blue Book tells investigators to ask about computer hardware and software systems continue to be valid and are asked by inspectors and auditors today for systems operating in regulated environments. (3)   In February 1983, the US Food and Drug Administration (FDA) published its first guidance focused on the accuracy and…

Read More

Index of Titles

  • 01. Successful Computer Validation
  • 02. Business Management Perspective
  • 03. Regulatory Perspective
  • 04. Users Team Role in CSV
  • 05. Auditable Computer Validation Package
  • 06. Blue Book History
  • 07. Formal Testing
  • 08. IT Role in Validation
  • 09. Software Supplier’s Role in Validation
  • 10. QA & QC Roles in Validation
  • 11. Electronic Archives
  • 12. Provenance and Original Order
  • 13. Archivist Values
  • 14. Corporate Role for Electronic Records Quality
  • 15. Why Validate a Computerized System?
  • 16. Why Document System Testing?
  • 17. Why can’t IT write a good system URS by itself?
  • 18. What Is the Hardest Part of a Test Plan?
  • 19. Why Write a Test Summary Report?
  • 20. What is a Platform Requirements Specification (PRS)?
  • 21. Validation and Outsourced IT Services
  • 22. Due Diligence Auditing of IT Services
  • 23. Audit and Validation Issues for “Cloud” Services
  • 24. Corporate Role for e-Record Quality
  • 25. System Sponsor Role in Computer Validation
  • 26. Developing a Good User Requirements Specification (URS)
  • 27. Developing a Good Platform Requirements Specification (PRS)
  • 28. Software Supplier Requirements – PRD/MRS/FRS
  • 29. Validation Package Model – Human Control
  • 30. Validation Package Model – System Control
  • 31. Validation Package Model – Testing Control
  • 32. The Installation Qualification (IQ) Package
  • 33. Installation Qualification (IQ) Package
  • 34. Installation Qualification (IQ) Package
  • 35. Performance Qualification (PQ) Package
  • 36. Software Development Practices – Software Architecture Document (SAD)
  • 37. Software Development Practices – SAD
  • 38. Software Development Practices – CASE Tools
  • 39. Software Development Practices – Code Reviews
  • 40. SW Dev Practices – Smoke Test
  • 41. Cloud Validation – PQ Testing of SaaS Applications
  • 42. Cloud Validation – Technology Challenges
  • 43. Cloud Validation – Safe Harbor Challenge
  • 44. Cloud Validation – FDA Part 11 Challenge for IaaS
  • 45. Cloud Validation – EMA GMP Annex 11 Challenge for PaaS
  • 46. Cloud Validation – End User Validation Challenge for SaaS
© 2019 GXP International
Website by ConcordWebBuilders
Scroll To Top