Compliance
CSV
Computer System Validation · computer system validation · computerised system validation
The formal process of proving a software system does what it should, reliably and predictably.
Computer System Validation (CSV) is the documented evidence that a computerised system consistently does what it was designed to do. In regulated manufacturing, CSV is required for any system that touches GxP data. The accepted framework is GAMP 5; the proof artefacts are URS, FS/DS, IQ, OQ, PQ, traceability matrix and periodic review.
Note: in some industries 'CSV' also means 'comma-separated values' — context matters.
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