Current approach to Computer System Validation (CSV)

 

Data Integrity App


The focus of current CSV processes is producing accurate and approved documentation to present information to auditors.

Auditors, such as the FDA, require evidence and records, therefore the CSV methodology inspires a compliance-mindset rather than an innovative one.

As such, existing CSV methodology results in manufacturers spending around 80% of their time producing documentation and only 20% of their time doing actual testing of the software.

CSV has morphed into an activity that is being done primarily to secure evidence for auditors, rather than to assure the quality of systems being validated.

The current CSV approach is seen as:
  • Deterrent to pursuing automation time, cost, use of automated testing tools, documentation generation etc
  • Regulatory burden (e.g., Data integrity) as an excuse for resisting progress; meanwhile, other regulated and nonregulated industries have moved forward and adopted frameworks for modern testing.
  • All software is being validated as if it is product software.
  • Burdensome and the creation of complex Risk Assessments.
  • Focusing on gathering evidence for auditors.
  • Duplication of vendor efforts at client site. 
  • 80% of deviations due to tester or test script errors.
  • Numerous post-go-live issues.

“Trust but Verify “ Ronald Reagan

 

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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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