What this is
A field reference for commissioning and qualification. Every system listed comes with ready-to-go draft IQ, OQ, and PQ test templates you can adapt, alongside a Typical URS, risk questions, and acceptance guidance. The Reference tab covers the methods, standards, and lifecycle behind them.
Equipment · find a systemReference · the framework
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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