SIMCA^® compliant with 21 CFR part 11 (Q733)

The information in this article applies to:

SIMCA^® 18

SIMCA^® 17

SIMCA^® 16

SIMCA^® 15

Summary:

To make SIMCA^® compliant with 21 CFR part 11, the Audit trail has to be turned on.

More Information:

An administrator can force the Audit trail to always be turned on by selecting the Lock Audit Trail check box during the installation of the software. See the document "Audit trail in SIMCA^®" for more information concerning the Audit trail. See also About the Audit Trail - Compliance with 21 CFR part 11 (Q732).

The attached document for SIMCA 16 is valid also for SIMCA 17 and 18.