Can a User's Name Be Modified? Audit Trail Captures Change. Is this Compliant with 21 CFR Part 11?
(Doc ID 2883109.1)
Last updated on JULY 13, 2023
Applies to:Oracle Life Sciences Argus Safety - Version 8.2.3 and later
Information in this document applies to any platform.
An Argus account was created in 2021 and it worked as expected.
The user name was Exxx Pxxxxx’s.
In Jan 2022 the user name was updated from the existing Exxx Pxxxxx’s to user name Txxx Gxxxxx.
This was reflected in the configuration/case processing Audit trail.
Specifically, all the existing Audit trail entries created by Exxx Pxxxxx’s were modified to show the new user name of Txxx Gxxxxx.
Is this intended functionality and is it still in compliance with 21 CFR Part 11?
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