How one QA team built a regulator-ready AI assistant for CAPA triage

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A quality assurance team developed an AI assistant to help manage a growing CAPA backlog by suggesting root-cause categories, surfacing relevant documents, and drafting corrective actions for human review. The prototype was tested in a sandbox using de-identified historical records, with AI suggestions logged but not acted upon, allowing comparison against actual human outcomes. The team found the tool useful but identified risks including plausible-sounding but incorrect rationales and hallucinated document citations. To meet 21 CFR 820 and ISO 13485 requirements, they validated the human-overseen assistance process rather than the AI model itself, building a golden test corpus, defining measurable acceptance criteria, and placing all outputs under change control. Continuous drift monitoring, strict data boundaries, and mandatory human review of all AI-generated drafts were built into the deployment to satisfy regulatory scrutiny.

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