The Adobe Self-Sign Digital ID electronic signature process has been validated and is considered compliant with FDA’s 21 CFR Part 11 regulation.
Who should use this e-signature process?
Researchers conducting FDA-regulated studies under an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application must in the absence of wet signatures, apply e-signatures using a 21 CFR Part 11 compliant system.
For FDA-regulated studies: If you need to e-sign a research document to be maintained as part of your study records, and the document cannot be signed within Complion, Velos, or other Part 11 compliant system, then you must e-sign the document using the Adobe Self-Sign Digital ID e-signature process. For example, if you need to add a note to file to your records, and this note cannot be signed within Complion, you must e-sign using the Adobe Self-Sign Digital ID e-signature process.
Highlights of the Adobe Self-Sign e-signature:
- Requires users to enter a password for every e-signature
- Meets FDA’s Part 11 requirement for signature manifestation (appearance):
- Indicates the signer’s printed name, date and time of signature
- Indicates the “reason” for signature (e.g. I am the author, I approve, etc.) as selected by user
Training and More Information:
- To start using this e-signature, please complete the online training module entitled, Adobe Self Sign Digital ID Electronic Signature, available in ULearn. Search keyword: digital id.
- File your training certificate with your research records.
- View Frequently Asked Questions here.
