CQV Field Reference

for commissioning, qualification and validation
What this is

A working reference for commissioning and qualification. Every system here comes with draft IQ, OQ, and PQ test templates you can adapt, plus a typical URS, the risk questions to ask, and guidance on what counts as passing. The Reference tab covers the methods, standards, and lifecycle behind all of it.

Equipment · find a systemReference · the structure
Source badges
Verified - primary standard (USP, ISPE, PDA, EN, ASME) or OEM, confirmed against the issuing body.
Corroborated - industry-supported figure from reputable validation/calibration sources, agreed across more than one.
Regulation (CFR) - required by US FDA 21 CFR (211 drug GMP / 820 device QSR) and its EU equivalent (EudraLex Annex 15 / Annex 11).
Site-defined - the limit is set by your URS, risk assessment, or data sheet, not a published standard.
Industry GMP - general good practice with no single specific citation.
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1What it ishow it works and what qualification means for it
2How much qualification it needsimpact and criticality
3What to require, and what to assessa typical URS, and the risk questions to ask
4The testsIQ, OQ and PQ, with the basis for each step
5Keeping it qualifiedrequalification triggers and the engineering documents to hold
6Working with the resultsthe statistics these tests produce