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DocuSign - FDA Part 11 signer authentication issue using vcuhealth.org email address

Updated 06/09/2025 02:58:34 PM
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Summary

Attempts to authenticate to DocuSign with a vcuhealth.org email address will be blocked by the VCUHS Single Sign-On. Internal envelopes are to be addressed using the VCU email (the eID@vcu.edu format), not the vcuhealth.org format.

Symptoms

Sender issues Part 11 envelope to a vcuhealth.org email address. Recipient receives a VCUHealth Single Sign-On authentication error (e.g., "User is not assigned to this application") when attempting to log in to access the envelope.

Environment

DocuSign eSignature CFR Part 11 domain for FDA-regulated research

Solution

Sender must issue a Correction on the envelope and change the vcuhealth.org email address to the recipient's VCU eID @vcu.edu email address.

Sender is directed to read the "DocuSign Part 11 Policy and Procedures" document, section "Procedures for sending envelopes," found at:

https://vcu.rightanswers.com/portal/app/portlets/results/viewsolution.jsp?solutionid=250115084524550

Cause

Shortly after VCU claimed the vcu.edu DocuSign domain in 2017, VCUHS claimed the vcuhealth.org DocuSign domain. VCUHS has restrictions on directly logging into DocuSign using vcuhealth.org email addresses, and the VCUHS Single Sign-On will prevent unauthorized vcuhealth.org email addresses from attempting to log into DocuSign. Part 11 senders are expressly informed in the DocuSign Part 11 Policy and Procedures document to use the vcu.edu address, not the vcuhealth.org, in order to avoid these issues. Otherwise, to authenticate to DocuSign using the vcuhealth.org email address, the recipient will have to contact VCUHS IT through the Employee Intranet (https://intranet.vcuhealth.org/) or 804-828-6447. VCUHS IT must change the login policy for users with a vcuhealth.org email address to not go through the VCUHS Single Sign-On when accessing DocuSign. All vcuhealth.org authentication issues to DocuSign must be referred to VCUHS IT. 

Outcome

After sender corrects the email address, the recipient will receive a new signing invitation link and will be able to access the Part 11 envelope.

Keywords: DocuSign FDA Part11 eSignature

Need help?

Call 804-828-2227

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Solution ID
240520150254530
Last Modified Date
06/09/2025 02:58:34 PM
Taxonomy
  • Communication and Collaboration > DocuSign
Collections
  • VCU (Public)

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