Unverified50% confidenceFactExact time
21 CFR 820.40 clearly distinguishes two types of objects, 'document changes' and 'records': documents (such as templates, procedures, specifications) can be revised, but records are evidence of completed activities and must not be retrospectively changed.
1
Sources
50%
Confidence
Long-term
Relevance
10/13/2026
First Seen
Sources
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