Home Forums TMF Management, Content & Processing Changing Metadata on final documents Reply To: Changing Metadata on final documents

Eldin Rammell

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.