Your Quality Team Is Already Using AI To Draft Compliance Documents

AI-assisted drafting of CAPAs, deviation write-ups, and regulatory correspondence is probably already happening on your quality team, with no policy and no record. This paper argues the exposure is not model reliability but the missing audit trail, and explains why a general-purpose model breaks the premise behind computer system validation. It reads FDA's January 2025 draft guidance alongside the January 2026 FDA and EMA principles, and notes what the draft guidance explicitly leaves out. It also offers a five-dimension scoring framework, from data handling to human oversight, for assessing how your team's AI use actually looks.

Examine the framework and see where your own exposure falls.