lab / notes
Study notes
Working notes on reading the regulation text and turning it into design.
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What an audit trail actually has to record — applying 21 CFR 11.10(e) and ALCOA+ to our own product
Breaking 21 CFR 11.10(e) into five concrete requirements and finding that our own "audit trail" met almost none of them.
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Looking for Japanese regulatory guidance on audit trail review — and not finding it
The 2022 Japanese GMP casebook mentions "audit trail" exactly once in 176 pages. So where should you actually look?