We use an eTMF, however, have not yet set up the e-Signature module for use in the system. Given the situation we are in currently, all employees are working from home. Clinical Study work still needs to progress and associated documentation needs to be ‘signed’. My question for the group:
Are companies using ‘DocuSign’ to sign documents? Does it need to be validated in order to use? Thanks in advance, Laura
as far as I know part 11 compliance can only be ensured if you use the Business Pro version of DocuSign. The esignatures with the standard version are not compliant for signatures on documents to be filed in the eTMF.
If I am wrong I would appreciate some comments as we are thinking of using implementing DocuSign, too.
We do use DocuSign and you are correct Benjamin it must be the validated version. Currently we use it for distinct document types e.g. vendor contracts, but not everything. We have been promoting the use of the e-signature workflow within our eTMF, but that is only helpful if all the signatories have access to the eTMF.
If you use DocuSign, to maintain Part 11 Compliance, you should ensure that it is validated for your hardware/software systems as well. This is typically done through User Acceptance Testing (UAT) and is probably handled by your IT department as all systems subject to Part 11 have to be validated and they likely have a procedure for it when there is new software implemented and/or there are updates. UAT can be contracted to a third party. Hope this helps.