Qualification

Qualification is the act of demonstration for the stable, stationary object – plant, equipment, and piping in GMP manufacturing, and likewise the IT infrastructure (frame of reference: EU GMP Annex 15; Annex 11, principle: validate the application, qualify the IT infrastructure). A state once qualified remains reliable under controlled conditions – the most stable object of evidence. As soon as the object moves or its inner workings change (software, AI), qualification falls short – verification is then the correct act. Distinct from verification (the movable and changeable) and validation (the overall system).