Opened 8 years ago

Closed 8 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)

21CFR11.pdf (150.2 KB ) - added by gstrylewicz 8 years ago.
FDA requirements on esig, section 11.50

Download all attachments as: .zip

Change History (5)

by gstrylewicz, 8 years ago

Attachment: 21CFR11.pdf added

FDA requirements on esig, section 11.50

comment:1 by car031, 8 years ago

Milestone: 8.0.1
Priority: majorminor
Type: bugwish

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 by car031, 8 years ago

Milestone: 8.1
Summary: Signature fails to record reason for signingRecord reason for signing (compliance with medial standard 21CFR Part 11)
Type: wishimprovement

comment:3 by car031, 8 years ago

Summary: Record reason for signing (compliance with medial standard 21CFR Part 11)Record the reason for signing (compliance with medial standard 21CFR Part 11)

comment:4 by car031, 8 years ago

Resolution: fixed
Status: newclosed
Note: See TracTickets for help on using tickets.