About the Audit Trail - Compliance with 21 CFR part 11 (Q732)

The information in this article applies to:

SIMCA^® 18

SIMCA^® 17

SIMCA^® 16

SIMCA^® 15

Summary:

The Audit Trail in SIMCA^® is Umetrics implementation to comply with rules for keeping electronic records (21 CFR Part 11). The Audit Trail is a log where changes to the project are logged. This article gives an introduction how the Audit Trail works.

More Information:

About the Audit Trail

Each project in SIMCA^® has a separate Audit Trail. Each Audit Trail consists of one or more sessions that in turn consist of events.

A new session is started and appended to the Audit Trail when a project is opened, and ends when the project is saved.In addition to logging events, SIMCA^® logs information about the user, and date and time of the events.

By default the Audit Trail is disabled. To turn it on, open the Options dialog on the File tab, in the SIMCA^® import and select Yes in "Log events to the Audit Trail". To turn on the Audit trail of an already created project, select the check box "Log events in the Audit Trail" in File | Project Options | Audit Trail. In this dialog you can also clear the Audit Trail for a project.

To hide or show the Audit Trail, on the View tab, select the Audit Trail check box.

Administrators can disable the possibility to modify the Audit Trail settings and control the behavior of the Audit Trail, i.e., always have it on. For instructions on how to disable the Audit Trail options, see SIMCA^® compliant with 21 CFR part 11 (Q733)

SIMCA^® uses Internet Explorer functionality to display the Audit Trail.