Reply To: Use of DocuSign in TMF

[Barbara Rusin]

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.