Part 11 requires secure, computer generated, time stamped audit trails independent of the operator, and a sovereign on premise review system with a sealed, tamper evident record is the cleanest way to meet it while using AI on batch records.
FDA's 21 CFR Part 11 demands audit trails that are computer generated, time stamped and independent of the operator. We explain why batch record review on your own hardware, sealed before every action runs, is the architecture the regulation describes.
Originally published on mickai.co.uk. This is a cross-post; the canonical version, with the full body, footnotes and references, lives on the mickai.co.uk article page.
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