Hello!
We are planning to archive our paper TMF in electronic format and need some guidance on which types of documents should be certified copies. Would we only need to certify those documents that have a wet signature? Or that were received in paper format originally?
For example, if we received an electronic file and then printed for the TMF, would we need to scan that copy back in and certify it? Could we use the original electronic file although it has been maintained in a non 21 CFR Part 11 system for the past few years? Or can that type of document be QC’d on a risk-based approach?
Thank you so much for your guidance on this matter!
Many warm regards,
Janet