FDA-Regulated Documents

Table of Contents


Terms of Use

The regulations in 21 CFR Part 11 set forth the criteria under which FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

Signing FDA-regulated documents with an electronic signature, specifically CFR - Code of Federal Regulations Title 21, Part 11 requires two levels of authentication;  the recipient will be instructed to enter the sender supplied password and create an account or log into their existing account at the time of signing to ensure compliance.

If you work with FDA-regulated documents and don’t see this logo when logged into your SignNow account, please contact the ITS Service Center and let the E-Signature team know that your SignNow account needs to be updated.

Due to the login requirement for recipients when completing FDA-regulated documents, if you need U-M staff, faculty, or students to sign your documents, please send the invite to their @umich.edu email and not any other umich extensions (such as @med.umich.edu) to ensure they are able to view and sign the document without issue. 

Resources

Quick Reference Guide for FDA-Regulated Documents

Institutional Review Boards - IRBMED

Document Requirements

With a SignNow FDA-Regulated document account, you will find:

  • The SignatureID / Timestamp setting is enabled to appear below the signature line on the download of a signed document.
  • A password will be required for every document sent for signature.
  • The recipient will be required to have a SignNow account for identity verification.

System Documentation

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