How should we deal with superseded/previous official versions for documents that are version-controlled (IB, protocol, etc.)? I am not talking about draft versions here.
For example for the Investigator’s Brochure, shall we keep “mixed” in the same folder “02.01.01_Investigator’s Brochure” the current version AND the previous versions? Or is it ok to add new sub-folders such as “Current Version” and “Previous versions” ?
Jessy – as far as I am aware, there is no “standard” answer to your question as it depends on the capabilities/best practices for the eTMF you are using. eTMF systems each have their own way of identifying different versions of the same document.
What is minimally important from an inspection perspective is that all expected superseded versions are present in your TMF.
The primary consideration for daily operations would be “can your staff easily identify the current version of a given record, separate from its superseded versions?”