Changing Metadata on final documents

[Anke Fronius]

Hello,
I often find myself needing to change metadata/document properties after uploading a document into the eTMF. E.g. because I want to add a link to a document that I only uploaded later or because I realized I made a mistake when entering the document data or I chose the wrong artifact.
In our new eTMF, I cannot do this on a final document. I will need to send the document to draft first, then change the metadata, then send to final again. This means each time I change the metadata, a new system version is created.
In the eTMF I used at my previous company, I was able to change metadata on final documents and only needed to send documents to draft if I wanted to make changes to the document itself.
What is your experience and what do you think are the PROs and CONs of being able to change metadata for a final document without creating a new system version?

[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.

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