The QMSR is live, but renaming 21 CFR 820 procedures is not migration
This story is from 2026-10-21. It is preserved in the archive; the latest stories are on the live feed.
A recent internal audit gave me the answer I did not want. I sampled a CAPA opened after a repeated supplier non-conformance. Its procedure had been retitled, its header cited ISO 13485:2016, clause 9.2, and its appendix mapped the former 21 CFR 820.100 to the new requirement. The underlying record…
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- 2026-10-21 09:52 · DEV Community — AI
The QMSR is live, but renaming 21 CFR 820 procedures is not migration