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Delay in eSignature Causing Compliance Concern

Audrey_Duran
Galactic 2
Galactic 2
0 Kudos

Hi - We are wondering if other validated customers have experienced any issue with learners eSigning at a later date  than when they completed their courses and this causing a concern with compliance/regulatory. Per the Code of Federal Regulations (CFRs), it is expected that CGMP-compliant record-keeping activities are documented at the time of performance (ALCOA). This is causing concerns in relation to our data integrity, that the date of completion does not match the date the course was eSigned. Has anyone else experience this concern from their compliance departments and has anyone been able to find a good solution?

Thanks in advance for your feedback!

- Audrey

3 REPLIES 3

robda01
Galactic 3
Galactic 3
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Are you seeing that records have been e-signed after a completion date is populated? I would think it would happen the other way around with e-signatures enabled (completion date not populated until signed).

Linda_Doherty
Galactic 2
Galactic 2
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We advise users to add a comment as to why they are signing off late, e.g. system access issue.  However we typically provide only the completion date in reports that we share during an audit, to avoid any confusion with the last updated date. We have not yet had any audit issues.

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Where exactly is this occurring again, UI or the report?

I see it working fine at our end.

-Dhruv