What is System Deliverable Matrix & Its usage in Computer System Validation?

In Earlier post we understood what is Checklist which useful for Computer System Validation Documents Preparation & Review.

Now in this article we are going to understand What is System Deliverable Matrix & Its usage in Computer System Validation?

What is Deliverable?

A deliverable is any unique and verifiable generated results, or capability to perform a service that must be produced to complete a process, phase, or project in computer system validation.

The list of deliverables which shall be generated by the project team based on the GxP Assessment & system categorization checklist and system level risk assessment.

The most important thing is to define the desired project results and work through the deliverables to each of them. The more defined the deliverables are, the easier it is to forecast the timeline, the budget and the scope.

System Deliverable Matrix is subjected in nature for guidance purpose, number of deliverables may be changed based on system risk, complexity & Novelty and same shall be defined in Project Validation Plan.

System Deliverable Matrix

1. Change Control Initiation Form
2. URS Initiation Record
3. Project Plan(schedule)
4. Change Control Approval Form
5. GxP Assessment & System Categorization Checklist
6. System Level Risk Assessment
7. Vendor Survey Form
8. Vendor Audit Report
9. URS Finalization Record
10. Project Validation Plan
11. Training Records
12. Functional Specification
13. Design Specification
14. Requirement Traceability Matrix Initiation
15. Functional Level Risk Assessment
16. Configuration Specification
17. Software Code Review Record
18. Installation Qualification, Operational Qualification, Performance Qualification Protocol
19. Test Scripts
20. Test Scripts Execution
21. Requirement Traceability Matrix Record
22. Installation Qualification, Operational Qualification, Performance Qualification Report
23. Discrepancy Form
24. Discrepancy Log
25. Infrastructure Qualification Protocol & Report
26. Data Migration Plan
27. Signature Identification Log
28. Risk Assessment Report
29. System specific Business & Technical SOPs
30. Validation Summary Report
31. System Release Certificate
32. Notification for Go live
33. Change Control Closure Form

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