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AI-ready · Stakeholder Communication

An FDA investigator asks during an inspection whether AI tools were used anywhere in preparing the batch record review or the CAPA narrative in front of them. How do you answer, and what do you need to have ready to back it up?

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I answer directly and specifically — where AI was used, for what task, and what verification sat on top of it — because vague or defensive answers read worse to an investigator tha…

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