lab
Lab — rebuilding Erlen into a record you can trust
An open log of adding audit trails, electronic signatures and exports to Erlen — decisions, dead ends and open questions included.
This is where Erlen is being rebuilt in the open — audit trails, electronic signatures, exports, and the documents needed for on-site validation. Nothing here claims regulatory compliance or certification. Articles are written in Japanese; each entry links to its Japanese original.
All entries
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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?
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Open questions — nine things we are unsure about in the audit trail design
Nine questions where the regulation text alone does not tell us what practitioners actually need.
Questions and corrections are welcome on GitHub Issues.