Adobe Acrobat Sign CFR Part 11 Compliance
Coming Soon
You must submit a request to Office of Research IT (coming soon!) for all 21 CFR Part 11 needs. Note: This process may take up to 2 weeks to complete the setup and review pending no IRB modifications are needed. Please plan accordingly.
Adobe Acrobat Sign is a digital signing software used to send documents online and collect electronic signatures remotely.
Adobe Acrobat Sign is the only University of Rochester approved 21 CFR Part 11 and HIPAA compliant option and is available for clinical research teams at the University of Rochester. Senders can upload documents to an electronic agreement, add fields for signature and date, and send the agreement to a specified recipient via email.
A few reminders:
- DocuSign eSignature or Adobe Acrobat Sign Standard is available for use at the University of Rochester. However, DocuSign eSignature is not 21 CFR Part 11 compliant.
- There is separate Adobe Acrobat Sign Part 11 account for sending agreements that require 21 CFR Part 11 compliance. No purchase of separate envelopes will be needed with Adobe Acrobat Sign.
- You must submit a request to Office of Research IT for 21 CFR Part 11 compliant set-up.
- A full-service review and set-up process will be required to use this service due to FDA audit requirements.
- This setup and review has a billable charge of $250.
- Adobe Acrobat Sign is not intended to be used as a document management system.
- New eSignature guidance has been updated. (link coming soon)