COMPUTERIZED SYSTEM VALIDATIONS GENERAL FLOW

S. Document
Document Name Remarks
No. Type
1. Protocol GAP Assessment Of Computerized Appendix S5
System Validation for the Client 2.2.1 Baseline Assessment
2. Policy Computerized System Validation Appendix M1
(CSV) Policy 4.1 General Guidelines
3. VMP Computerized System Validation Appendix M1
Master Plan (CSVMP) 4.1 General Guidelines
4. SOP Procedure For Computerized System Appendix M4
Validation 3.6 Typical Examples and Approaches
5. SOP Procedure For Administration of Appendix O12
Computerized System System Administration
SOP Procedure For Preventive Maintenance Appendix D5
6. and Performance Monitoring of 9.1.1 Installation Testing of
Computerized System Hardware/Software
7. SOP Backup & Restore of Computerized Appendix O9
System Backup and Restore
8. SOP Disaster Recovery of Computer Appendix O10
System Business Continuity Management
SOP Inventory Management of Appendix D5
9. Computerized System 9.1.1 Installation Testing of
Hardware/Software
10. SOP Procedure For Retirement of Appendix M10
Computerized System System Retirement
11. Annexure Codes of Computerized Systems --
12. Annexure Register of Computerized Systems --
13. Annexure History Card of Computerized --
Systems
14. Annexure Preventive Maintenance Schedule of --
Computer Systems
15. Annexure Preventive Maintenance of Computer --
Systems
16. Annexure Desktop Policies of Computerized --
Systems
17. Protocol Protocol of Computerized System --
Validation
18. Annexure Scope Of Computerized System --
Validation Inventory
19. Annexure Initial Risk Assessment --
20. Annexure Configuration of Desktop Policies Execution part for each system
(Applicable to Server(s))
21. Annexure Report of Desktop Policies --
(Applicable to Server(s))
22. Annexure Desktop Policies Assessment --
(for all desktops & laptops)
23. Annexure Report of Desktop Policies --
Assessment
(for all desktops & laptops)
24. Annexure Risk Assessment of computerized --
system
25. Annexure Functional Assessment of Application --
26. Annexure Part 11 Assessment of Application --

27. Annexure Traceability Matrix --

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