Thanks for replying to my question. I reviewed the previous thread and have a follow-up question to your response:
“Hopefully your eTMF system already has (or can be setup with) a process for a user to upload a scan of a wet-ink document and attest that the scan is an exact copy of the original, with all of the same attributes and information. In this way, your eTMF audit trail captures the relevant information about this important decision.”
I have not used eTMF systems, therefore can you explain more what you meant by the system has a process for the user to attest that the scan is an exact copy of the original? Typically, what does that process look like? Is there something for the user to check after they have uploaded the document – and then that gets recorded in the audit history? Also, is that only a requirement for documents with wet ink signature?
If a site does not have a eTMF system set up that way, can you provide some examples of other methods for certifying documents with wet ink signature?
Thanks again for taking time to respond.