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Digital Manufacturing

Infographic: Computer System Validation Vs. Computer Software Assurance

Business consultants planning digital transformation strategy and enterprise IT solutions in a team meeting.

Computer Software Assurance (CSA) aims to put critical thinking at the center of Computer System Validation (CSV) processes. 

In our latest infographic, we highlight the main differences between traditional CSV and the new CSA approach. 

Computer System Validation versus Computer Software Assurance infographic comparing traditional CSV with new CSA, including risk-based assurance, reduced testing burden, supplier collaboration, fewer deviations, and critical thinking for safe software use.

Traditional CSV

  • Perceived as a barrier to automated solutions and innovation

  • All software is validated as if it’s product software

  • The primary focus is securing evidence for auditors

  • Duplication of vendor documentation and effort

  • High occurrence of deviations due to tester error

 

New Computer Software Assurance

  • A more flexible, less burdensome, and faster risk-based approach

  • Various assurance approaches depending on the system/feature risk

  • Apply critical thinking to ensure the software is safe and meet its intended use

  • Reduced testing activities resulting from better supplier qualification and collaboration

  • Reduced number of deviations due to tester error