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Signing a 21 CFR Part 11 compliant document in DocuSign
21 CFR Part 11 is an FDA regulation that relates to research - UCSF has a separate DocuSign instance that has additional policies and regulations in place to meet the 21 CFR Part 11 guidelines.
Signing a 21 CFR Part 11 compliant document is slightly different process than signing a normal envelope. Please see the steps outlined below.
When a user receives a Part 11 compliant document they will need to have a DocuSign account in order to sign it. Upon receiving a Part 11 envelope the users will know that it requires authenticating with DocuSign because it states that the Part 11 module is enabled.
1. After selecting "Review Document" signers will be routed to the DocuSign login page. If the signer does not already have a DocuSign account, they will be prompted to create one and set up a password. Please remember the password - it will be needed again soon.
2. Once the signer has logged in they will be able to begin signing after agreeing to the disclosure.
3. Once the signer clicks on one of the signing fields above, they will be directed to the following screen to select reason for signing.
4. In the drop-down select a reason for signing. In most cases, the signer will select "I approve this document" and click sign which will redirect them to this pop-up.
5. The signer will click continue and then be redirected back to the login page where they will have to authenticate again. They will also need to re-authenticate for each initials field.
Signers will have to repeat steps 3-5 until all signing is completed and then click Finish to get to this screen
Video on signing a 21 CFR Part 11 DocuSign envelope: https://support.docusign.com/en/videos/Sign-a-CFR-Part-11