7.3 User administration
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[New]
Add a new reason to the list.
[Delete]
Delete the selected reason from the list.
[Edit]
Change the designation of the selected reason.
7.3.7 Audit Trail
Main dialog: System â–¶ System settings â–¶ User admin. â–¶ Login
options â–¶ Audit Trail
An Audit Trail is an automatically generated log of all user activities. An
Audit Trail contains precise logs of user actions (date, time, user, action,
etc.). Recording an Audit Trail is important for compliance with FDA Guid-
ance 21 CFR Part 11 when using PC programs. A step-by-step description
of how you must proceed to remain in compliance with the FDA Guidance
is included in the document Compliance Guide Touch Control. The Audit
Trail is saved to the internal memory.
You can also use the Audit Trail function specifically to record the data
which are of interest to you.
You can view, filter and export the Audit Trail on a PC with the supplied
software program AuditTrailViewer. Details concerning utilization of the
AuditTrailViewer can be found in the Appendix (chapter 31.7, page 301).
If necessary, you can delete all of the entries in the Audit Trail with
[Delete Audit Trail]. Do not fail to create a backup before doing so,
however.
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