Sector · GxP · 21 CFR Part 11 · Annex 11
AI under GxP, with the IQ, OQ and PQ documents written
Pharma clients use Exec × AI when AI sits inside a GxP boundary and the validation file has to stand up to an FDA or MHRA inspection.
GxP · IQ · OQ · PQ
How the sector reads
You will receive the IQ, OQ and PQ documents in the format your validation team already files. Annex 11 and 21 CFR Part 11 controls are mapped on the same control sheet.
Computer-system validation effort is reduced by approximately 35 to 50 per cent against a manual baseline, based on two GxP deployments. The effort saving is largest in the OQ phase.
Where a use case sits outside GxP and could be deployed faster outside the validation cycle, we say so. Not every pharma AI case is GxP.