Final Checklist which made your Computer System Validation Documents Preparation & Review Easy

 


 

In Earlier post we understood what is System Release Certificate (SRC) in computer system validation?


Now in this article we are going to understand Checklist which useful for Computer System Validation Documents Preparation & Review.


The checklist items provide a frame of reference for users and auditors to better determine potential compliance issues with computer system validation.

 

All items in the checklist should be checked effectiveness of CSV for individual systems, especially where those systems use different control measures.


This checklist will enable you to systematically assess the strengths and weaknesses of a computer system validation using a uniform approach.


This checklist can be used to evaluate potential validation contract vendors/suppliers (front cover letter included).


This checklist was created in line with regulatory requirements of your computer system validation such as FDA 21 CFR Part 11 Electronic records and electronic signatures.


References will be provided for each checklist item to indicate where the requirement comes from.

 

Checklist for CSV program:

•       Change Control Initiation

•       URS Initiation

•       Project Plan (schedule)

•       Change Control Approval

•       GxP Assessment & System Categorization

•       System Level Risk Assessment

•       Vendor Survey

•       Vendor Onsite Audit

•       Vendor Audit Report

•       URS Finalization

•       Project Validation Plan

•       Training Records

•       Functional Specification

•       Design Specification

•       Requirement Traceability Matrix Initiation

•       Functional Level Risk Assessment

•       Configuration Specification

•       Software Code Review

•       Protocol Installation Qualification, Operational Qualification & Performance Qualification

•       Test Scripts Execution

•       Requirement Traceability Matrix

•       Report Installation Qualification, Operational Qualification & Performance Qualification

•       Discrepancy Form & Its 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

•       System Retirement & Decommissioning



“Trust but Verify “ Ronald Reagan

 

Across the internet, there are millions of resources are available which provide information about Everything.

 

If you found all content under one roof then it will save your time, effort & you will more concentrated on your important activity.

Data Integrity App


 

Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.

 

Data Integrity App Include 

- Basic Data Integrity Concepts

- ERES & Its Requirement

- CSV & Its best practices 

- Mock Inspection and General Q&A

- Checklist for inspection

- Inspection Readiness

- Useful SOP’s

- Stay Regulatory Compliant.

 

“Stay One Step Ahead in Pharma IT Compliance” 


Data Integrity App Link:


https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity

 

Try our "Data Integrity" app which helps you to better understand current regulatory agencies thinking on Data Integrity & CSV.


 


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