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.
Reference the Institutional Review Board (IRBMED) website to determine if you need an FDA-Regulated account. 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.
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.
- Inviting Recipients to FDA-Regulated Documents
- Understanding the recipient's experience when signing FDA-regulated documents
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