Acrobat Sign 21 CFR Part 11 ERES is a cloud-based electronic signature service and is fully validated to meet the electronic record and electronic signature requirements established by the FDA as part of 21 CFR Part 11 specifications for the replacement of paper-and-ink signature with 100% digital workflows. With this Adobe Document Cloud solution, you can easily send, sign, track, and manage signature processes and electronically sign (e-sign) GxP digital documents on any device, from any location.
This application is specific to Yale documents and records that are required to be in compliance with the e-signature/e-record FDA requirement, including, but not limited to, laboratory records, protocols for non-clinical studies and results, IND filings, inspection records, and training records.
Electronic signature functionality is made available to active users within an organization’s Adobe Acrobat Sign account and to external users. Authorized users with the appropriate access credentials,
- may upload a document in the Adobe Sign portal
- send an email notification to inform each authorized signer that the document is available for signature.
- may sign the documents from any device through a secure web browser session
For each signed record, an audit report is created. The audit report includes the identity of each signer and a timestamp indicating the date and time at which the signature was applied.
The signed record and its audit report can be retrieved for retention in MS SharePoint in accordance with applicable organizational retention policies.
Acrobat Sign User Access & Training
To obtain access to the validated 21 CFR Part 11 Acrobat Sign, please complete the online user access request form (this will need to be completed by the intended user’s manager). Once the request form has been submitted, the intended user will be contacted via email with the link to complete the required training.
Please review the below steps for application access:
- Obtain management approval for the use of the application
- Manager completes online access request form
- User completes required training
- Completion of the attestation form after training containing both manager and user signatures
- Submission of the signed attestation form to firstname.lastname@example.org
- Access is granted upon receipt of the attestation form. System administrator adds the new user to the Acrobat Sign 21 CFR User group and notifies the user
Revocation of Access
- Managerial responsibility:
- The user’s manager is responsible for notifying the administrators in the event the user departs from Yale, changes departments or no longer has need of the application.
- User responsibility:
- The user is responsible for ensuring their access is maintained properly.
Guidance Documents & Tools
- Validation Summary Report1 for Electronic Signatures in Adobe Sign, YCCI-SIGN-ESIG-VSR-01-PROD, Revision 01, Approved 06/23/2023
- ICH Harmonised Guidelines - Good Clinical Practice E(2) Nov 2016 and E6(R3) DRAFT 19 May 2023
- FDA 21 CFR Part 11, Electronic Records; Electronic Signatures - Scope and Application Guidance for Industry SEPTEMBER 2003
- FDA Guidance for Industry – Computerized Systems Used in Clinical Trials April 1999
- 9 March 2023 EMA/INS/GCP/112288/2023 Good Clinical Practice Inspectors Working Group (GCP IWG) Guideline on computerized systems and electronic data in clinical trials
- KB0026313 Digital Signatures: Adobe Acrobat Sign's FDA 21 CFR Part 11 features for GxP documents
- KB0025571 Digital Signatures: Adobe Acrobat Sign Enterprise frequently asked questions