Validation

 1. Computer System Validation Overview

2. Validation Plan

3. Validation Master Plan

4. User  Requirement Specification 

5. Requirement Tracebility Matrix

6. Computer System Validation (CFR -21 PART-11)

7. What is Validation

8. Computer System Validation CFR 21 Part 11 (Sub Part Guideline)

9. Computer System Validation EU Anne-11 Guideline

10. Key Point of Computer system Validation 

11. Functional Requirement

12. Design Specification

13.Test Protocol and Test Plan

14. Installation Qualification

15.Performance Qualification

16.Validation Summary Report

17. Validation Terminology 

18. Change Control for Validation System

19. Deviation Management for Computer System

20. Operational Qualification

21. Risk Assessment for Validation 

22. Computer System Assurance (Formal Writing)

23. OQ Testing Approch

24. IQ Testing Approch