Comark EV SOFTWARE - Manual (Page 22)

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Select View/print Audit trail:
It is now possible to view the current Audit trail for the software.
The Audit trail shows by date/time the action completed, the user, user ID, Task ID and
Session ID.
There are a number of filters for the Audit Trail:
•
Date Range
•
User
•
Task ID
•
Session ID
•
Maximum number of readings to display.
The filtered results are then exportable to Excel.
The results can be printed in either detailed form or as just the summary information.
The audit trail for any given database will be saved when archived so that it can be
reviewed when the archive database is reviewed.
12.5 21 CFR Part 11 Policy Statement
Comark does not at any time imply that the use of this software package and Comark
EV loggers will automatically give the customer protection and compliance with 21 CFR
Part 11. The EV Pro software from Comark is designed to be integrated into the SOPs
as part of a 21 CFR Part 11 system. A number of tools have been put into place in order
to provide an excellent basis for complying with the requirements of 21 CFR Part 11.
If the SOPs are updated to include the use of EV Pro and loggers then compliance is
not guaranteed but it will be more likely. In any case the system in place will need to be
discussed with an FDA Auditor. EV Pro and EV data loggers are a vital link in the path to
compliance.