Record the reason for signing (compliance with medial standard 21CFR Part 11)
Electronic signatures used in medical research settings need to be 21CFR Part 11 compliant, which states, in part:
(a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: (1) The printed name of the signer;
(2) The date and time when the signature was executed; and
(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
When I electronically sign a document, the reason is a required field and is added to the PDF, if configured for a visual sign. Otherwise, the reason is not recorded in the database and not displayed as part of the signing information.
Change History
(5)
| Milestone: |
8.0.1
|
| Priority: |
major → minor
|
| Type: |
bug → wish
|
| Milestone: |
→ 8.1
|
| Summary: |
Signature fails to record reason for signing → Record reason for signing (compliance with medial standard 21CFR Part 11)
|
| Type: |
wish → improvement
|
| Summary: |
Record reason for signing (compliance with medial standard 21CFR Part 11) → Record the reason for signing (compliance with medial standard 21CFR Part 11)
|
| Resolution: |
→ fixed
|
| Status: |
new → closed
|
FDA requirements on esig, section 11.50