Testing & Quality
What is Computer System Validation (CSV)?
Documented evidence that a computerized system consistently performs as intended in regulated (GxP) environments.
Life sciences ERP programs follow GAMP 5 and FDA 21 CFR Part 11 requirements, including validation plans, IQ/OQ/PQ, and traceability. Computer Software Assurance (CSA) promotes risk-based, critical-thinking approaches. Validation increases test documentation effort significantly.
Related terms
Requirements Traceability Matrix
A matrix linking requirements to design, build objects, test cases, results, and defects.
Test Evidence
Artifacts proving test execution and results, such as screenshots, document numbers, logs, and reports.
Audit Trail
Chronological evidence of who did what and when, used to demonstrate control and compliance.
Risk-Based Testing
Prioritizing test scope and depth by the likelihood and business impact of failure.
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