Hi RAPScommunity. My team is currently working on creating an email communication guidance in order to streamline the process of filing site emails in our eTMF to ensure we are audit ready. We are using the TMF Reference Model e-Mail Communications in Clinical Studies Guidance version 31-Jul-2020 (tmfrefmodel.com) as our primary resource but are having trouble working on developing a plan for our team which is not too burdensome and time consuming for the person responsible for filing the emails as well as ensuring that we are following the appropriate guidelines set by regulatory authorities.
The guidance document emphasizes that emails in the eTMF should be searchable in order to be ready for auditors. However, our eTMF that we are using automatically converts emails to PDFs so they are not searchable. Has anyone had a similar issue with their eTMF system not being searchable and if so, does anyone have any advice or lessons learned?
------------------------------
Allison Campbell
Regulatory Document Project Manager
Boston MA
United States
------------------------------