IQ, OQ and PQ

Installation qualification, operational qualification and performance qualification are the staged checks that equipment or software was installed correctly, operates as specified, and performs in real use.

IQ records that the system was installed according to the specification: versions, environment, access. OQ challenges the functions against limits: an approval route works, a signature is captured, a wrong login is refused. PQ shows the system in the actual process, with the people and data you really use. For simple tools a risk-based computer software assurance plan may combine or reduce these stages. For production equipment they are often still written as three protocols.

ISO 13485 clause 4.1.6 and process validation under 7.5.6 are the usual QMS hooks. The old 21 CFR 820.70(i) software-validation language is the US reference many files still cite while teams move to QMSR and to FDA's computer software assurance guidance.

HAVGATE Business and Enterprise plans include an IQ/OQ documentation package for the platform, as stated on the audit plans. You still write intended use and you still test the workflows you configured. The package does not complete PQ for your process by itself.