DocuSign - FDA Part 11 Getting Started

Summary

DocuSign Part 11 accounts are separate from the standard VCU DocuSign domain accounts. The DocuSign Part 11 domain account is compliant with federal regulation 21 CFR 11. Systems that comply with 21 CFR 11 are configured under certain specifications to ensure that the electronic records and electronic signatures executed in the system are equivalent to a handwritten signature on paper. These systems comply with specific validation standards to ensure that they meet the requirements of 21 CFR 11.

Environment

DocuSign eSignature Part 11 domain

Solution

To be provided with a DocuSign Part 11 account, please:

  1. Complete the required DocuSign Part 11 training (note that all individuals using DocuSign--whether under the Part 11 or the standard DocuSign account--are expected to have completed all foundational DocuSign training).
  2. Thoroughly review the DocuSign Part 11 Procedures for Site Administrators and Senders document, particularly the section regarding addressing envelopes using the eID@vcu.edu format of the email address, not the vcuhealth.org format. Steps to switch between the standard VCU DocuSign account and the Part 11 account are also found in the Procedures document. All individuals seeking a Part 11 account affirm that they have read and understood the document prior to being issued an account. 
  3. Ensure that you have read and understood the issues with Adobe Acrobat-specific features in PDFs uploaded to DocuSign.

Additional Information

Once training has been completed, OVPRI will create an account for this version of DocuSign and will send an email to you once complete.

NOTE: there are no custom permission sets on the Part 11 system. Therefore, there is no option for senders to be able to create templates under Part 11.

This version of DocuSign at VCU should be limited to study documents that relate to FDA-regulated studies. This version of DocuSign can also be used for eConsent as long as eConsent has been approved by the Institutional Review Board (IRB) of record for that particular study. Documents signed in this system should be downloaded from the system, in addition to the generated audit trail, and should be stored in the study’s respective binder in accordance with state, federal and university record retention requirements.

Access to Part 11

Account provisioning is done by the Office of the Vice President for Research and Innovation (OVPRI).  To gain access to the system, please complete the required DocuSign Part 11 training. Once training has been completed, OVPRI will create your account for this version of DocuSign and will send you an email.

Support Contacts

Account provisioning:
OVPRI research IT: erahelp@vcu.edu

Signer or sender-related issues:
Central IT DocuSign group: docusign@vcu.edu

Please remember that envelopes sent to VCUHS members must be addressed to their eid@vcu.edu email address, not to the vcuhealth.org email address. 

Policy/procedure or questions on system use:
Lauren Wallace, MS, RAC-Drugs
Director of Clinical Research Regulatory Affairs
kanigherl@vcu.edu

 

Solution Properties

Keywords
DocuSign FDA eSignature CFR
Solution ID
250115084524550
Last Modified Date
08/12/2025 09:15:55 AM
Taxonomy
  • Communication and Collaboration > DocuSign
Collections
  • Employees (Auth)
  • IT Professionals (Auth)
  • Students (Auth)
  • Technology Services (Auth)
  • VCU (Auth)
  • VCU (Public)
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