Computer Software Assurance

Transition from CSV to CSA Without the Compliance Risk.

Embrace the FDA's guidance on critical thinking. Stop generating paper for the sake of compliance, and focus your testing efforts where patient safety actually matters.

Built for GAMP 5 Second Edition

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Integrated Risk Assessments

Map every user requirement directly to patient safety, product quality, and data integrity risks. Automatically scale your testing strategy based on the resulting risk score.

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Unscripted & Ad-Hoc Testing

For low-risk, out-of-the-box software features, ditch the step-by-step test scripts. ValiTrail natively supports documenting unscripted and exploratory testing sessions.

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Leverage Vendor Documentation

Why test what the vendor already tested? ValiTrail allows you to seamlessly link vendor FAT or release testing documents directly to your Traceability Matrix to justify reduced OQ efforts.

Traditional CSV
  • Testing everything with the same level of rigor
  • "Death by documentation" and screenshots
  • Focus on generating paper to prove compliance
  • Months of validation delays for minor software updates
Modern CSA with ValiTrail
  • Rigorous testing reserved ONLY for high-risk, custom code
  • Screenshots only taken when a test fails or captures critical data
  • Focus on critical thinking and software quality
  • Agile validation that keeps pace with modern SaaS updates