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

 

Data Integrity App 

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

•         Change Control Initiation form

•         URS Initiation Record

•         Project Plan(schedule)

•         Change control approval form

•         GxP Assessment & System Categorization Checklist

•         System Level risk Assessment

•         Vendor Survey Form

•         Vendor Audit Report

•         URS Finalization Record

•         Project Validation Plan

•         Training Records

•         Functional Specification

•         Design Specification

•         Requirement Traceability Matrix Initiation

•         Functional Level Risk Assessment

•         Configuration Specification

•         Software Code Review Record

•         Installation Qualification, Operational Qualification, Performance Qualification Protocol

•         Test Scripts

•         Test Scripts Execution

•         Requirement Traceability Matrix Record

•         Installation Qualification, Operational Qualification, Performance Qualification Report

•         Discrepancy Form

•         Discrepancy Log

•         Infrastructure Qualification Protocol & Report

•         Data Migration Plan

•         Signature Identification Log

•         Risk Assessment Report

•         System specific Business & Technical SOPs

•         Validation Summary Report

•         System Release Certificate

•         Notification for Go live

•         Change Control Closure Form

 


“Trust but Verify “ Ronald Reagan

 

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- ERES & Its Requirement

- CSV & Its best practices 

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- Useful SOP’s

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