over the last time documents were increasingly signed electronically but at the same time paper TMFs are still used.
We are wondering what is the correct way to store electronically/ digitally signed documents in a paper TMF?
One could handle it using the inverted process of generating certified copies (generating a paper document form the electronically signed document) after which the electronic original could be destroyed.
However this might sometimes be tricky or impossible in case of digital signatures.
Another feasible option would maybe be to:
– Print the document with the Audit Trail and file it in the paper TMF
– Save the electronic originals in case they are required for paper verification.
How would you handle this process?
Do you already have a best-practice in place?
You know I once faced a document with 4 types of “sigantures” from all the document contributors:
1. Signed in Wet-ink
2. Signed by Adobe
4. The eSignature workflow configured in the study eTMF system.
I don’t know how to put this. Maybe every signature took individually is validated, but 4 in 1 document, I’d doubt it