Opened 7 years ago
Closed 6 years ago
#879 closed improvement (fixed)
Record the reason for signing (compliance with medial standard 21CFR Part 11)
Reported by: | gstrylewicz | Owned by: | |
---|---|---|---|
Priority: | minor | Milestone: | 8.1 |
Component: | Digital Signature | Version: | 8.0 |
Keywords: | reason | Cc: |
Description
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.
Attachments (1)
Change History (5)
Changed 7 years ago by gstrylewicz
comment:1 Changed 7 years ago by car031
- Milestone 8.0.1 deleted
- Priority changed from major to minor
- Type changed from bug to wish
This is not a bug, this sounds like a wish or a feature request.
You reference a regulation but the compliance to that regulation in not in the LogicalDOC's features list. If you need this to be implementec shortly plase contact the sales to have a quote.
comment:2 Changed 6 years ago by car031
- Milestone set to 8.1
- Summary changed from Signature fails to record reason for signing to Record reason for signing (compliance with medial standard 21CFR Part 11)
- Type changed from wish to improvement
comment:3 Changed 6 years ago by car031
- Summary changed from Record reason for signing (compliance with medial standard 21CFR Part 11) to Record the reason for signing (compliance with medial standard 21CFR Part 11)
comment:4 Changed 6 years ago by car031
- Resolution set to fixed
- Status changed from new to closed
FDA requirements on esig, section 11.50