DocuSign – 21 CFR Part 11
FDA 21 CFR Part 11 regulation covers document signing and records retention for processes and documents specified by the FDA. DocuSign’s 21 CFR Part 11 module has been designed to be incorporated as part of an “open system” system solution, as defined in Section 11.3(b)(9), in which there is electronic communication among multiple persons and where system access extends to people who are not part of the organization that operates the system. Source:
For information on how DocuSign meets 21 CFR Part 11 Compliance Requirements, please visit DocuSign’s Part 11 Compliance webpage.
If you believe you need to send documents for eSignature via DocuSign, consult with your department supervisor to determine whether you should request sender access.
If validated by your department supervisor, go to the ServiceNow DocuSign Sender Access request, and complete the steps to gain permission to deliver documents for eSignature via DocuSign.
Now that you have access, you’ll just need to switch accounts from your Standard DocuSign Account to your 21 CFR Part 11 DocuSign Account. Please note that you may also need to switch servers. We have included those steps below.
- Select your profile image to show the account actions menu. The account listed next to your image is the current account currently in use.
- Select Switch Accounts.
- In the Select an Account dialog, select the account to switch to.
Switching Accounts Tutorial Video
Required Training for Part 11 DocuSign
Faculty and staff who wish to send documents for eSignature (i.e., a document sender) through Part 11 DocuSign should complete the DocuSign FDA Part 11 eSignature training in Learn@Work.
Optional Training for Standard and Part 11 DocuSign
Faculty and staff who are interested in gaining more knowledge in DocuSign can complete any of the additional optional DocuSign training in Learn@Work.
Additionally, curated training and documentation can be found on the WashU IT DocuSign Resources & Support page.
Faculty and staff who are accessing the Standard DocuSign or Part 11 DocuSign as an envelope recipient with only viewer/signer privileges can view the 1-3 minute videos provided by DocuSign on YouTube.
Some features and functions available with the DocuSign standard account might not be available with the Part 11 module.
For more information, go to DocuSign CFR Part 11 Module – Features and Functions Not Available.
For Standard DocuSign and Part 11 DocuSign, you may receive email requests from your WashU colleagues to view and sign documents via DocuSign. Once you select “Review Documents” in the email, you will be prompted to register with DocuSign before you are able to view or sign documents. Register by entering your WashU email address followed by your WUSTL Key credentials. Thereafter, to view and sign documents you will be required to enter your WUSTL Key credentials.
DocuSign offers 1-2 minute YouTube video tutorials for users who are accessing DocuSign as a viewer/signer recipient. Additionally, your department supervisor may send you a test document to practice using DocuSign before you start viewing and signing study forms.
If you believe you need to send documents for eSignature via DocuSign, consult with your department supervisor to determine if you should complete the ServiceNow DocuSign Sender Access request.
Review the WashU Part 11 DocuSign SOP Document (PDF)
For additional FAQs, view the WashU Part 11 DocuSign FAQs Document (PDF)