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May 16, 2024 at 5:40 pm
#5155

Participant
Hi Anke
I can’t really see any CONS having the ability to change metadata without up versioning, assuming you have a full audit trail as required by regulations (ALCOA+ etc). This is standard for most commercial eTMF. I hope it is not too controversial to suggest that requiring a document be upversioned to change metadata is a major issue and could cause problems. Documents are usually only revised to change the content. It is not great practice to change a document from v1 to V2 (perhaps requiring re-signing) just to correct an administrative error in metadata.