Context: Computer System Validation (CSV) is the documented process for validating computerized systems. It demonstrates that a system is fit for its intended use, functions reliably and supports regulated processes or electronic records under control.
Why it matters: In GxP environments, CSV is a key prerequisite for audit-ready operation. CSV makes requirements, risks, tests, deviations, approvals and changes traceable and supports data integrity, patient safety, product quality and regulatory compliance.
Typical components:
- Validation plan and risk-based system assessment.
- Requirements, specifications, traceability and test evidence.
- Qualification via IQ/OQ/PQ.
- Deviation management, approvals and validation report.
- Change control, revalidation and controlled operation across the system lifecycle.
Distinction: This refers to the validation of computerized systems, not the CSV file format in the sense of comma-separated values.
Short version: CSV provides documented, risk-based evidence that a computerized system fulfils its intended purpose and can be operated under control in a validated state.
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