CSV
Computer System Validation. Documented evidence that a computerised system does what it is intended to do, reliably and repeatably.
CSV is the discipline of proving, with evidence a stranger could follow, that a system fits its intended use in a regulated process. It spans the lifecycle: requirements, risk assessment, testing, release, and the controls that maintain the validated state afterward.
Its reputation problem comes from decades of conflating evidence with volume. The modern, risk-based reading, pushed along by CSA and GAMP 5's second edition, treats documentation as a means and critical thinking as the activity. The systems did not change; the proportionality finally did.
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All CSVCSV/Jun 2, 2026/8 min
CSA is not the end of CSV. It is CSV finally done right.
FDA's Computer Software Assurance guidance was read by half the industry as permission to stop validating. The other half read it correctly.
CSV/May 21, 2026/7 min
The GAMP 5 software categories, explained like a human
Category 3, 4 or 5 decides how much validation work you are signing up for. Here is how to call it correctly, with a tool that does the asking.