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Todd Tullis

Hi Caitlin…opinions on this topic vary, as does the meaning of “in the eTMF” (if a document version is in an eTMF system but that version is not visible to an auditor user…does that mean the version is in the eTMF? 🙂

In the USA, my experience has been that most Sponsors/CROs feel interim versions should not be present in an eTMF. Some eTMF systems will purposefully delete interim versions when a given document is approved.

For auditors that are taking a business process approach (e.g. MHRA), you’ll want to have some way of proving that your SOPs were followed. Having interim versions of documents can sometimes help with this, but may not be needed depending on your eTMF’s capabilities in this regard.

Even if you have interim versions in your eTMF system, an auditor may not have permission to see them. Again this depends on your eTMF’s capabilities.