Work Flow of Documentation CSV Validation

   

 Required Documentation and Flow for Computer system validation

Sr. No.	Documentation
1	Change Control
2	Regularity Assessment @ System Assessment @ Cloud Assessment @ Data Integrity Assessment @ General Data Regulation
3	System Boundary
4	User Requirement Specification
5	Vendor Selection
6	Vendor Assessment
7	Vendor Audit
8	Vendor Requirement Acceptance Test
9	User Acceptance Test
10	Functional Requirement  Specification
11	Pre Factory Acceptance Test
12	Post Factory Acceptance Test (Optional)
13	Design Specification
14	Configuration Baseline
15	Software delivery (Machine Delivery)
16	Site Acceptance Test (When Required)
17	Validation Plan
18	Functional Risk Assessment
19	Infrastructure Configuration Assessment
20	Test Plan
21	IQ,OQ,PQ,IOQ,OPQ,PQ
22	Data Migration Plan
23	User Acceptance Protocol
24	Test Report
25	Requirement Traceability Matrix
26	System Support Plan
27	System Backup and Disaster Recovery Plan
28	User Guide
29	Administrative Right
30	Training Plan
31	Business Process Continuity Plan
32	Data Governess Plan
33	System Release Certificate
34	Validation Summery Report
35	Change Implementation Report
36	Decommission Plan
37	Decommission Report