Kaye Validator AVS - Audit Trail

Chapter 10. Generating Reports
Kaye Validator AVS User’s Manual 107
Validator AVS Audit Trail
The Kaye Validator AVS audit trail provides a complete listing of events that affect the integrity
of the Kaye Validator AVS PC program and the Kaye Validator AVS instrument. Audit trail
events are stored in secure data files to help you meet 21 CFR Part 11 requirements.
10.2.5 Audit Trail
The Kaye Validator AVS software maintains the audit trail, which contains all events and
identifies the type of action performed, the date and time the action occurred, the user ID of the
responsible operator, and any additional information required to understand the action taken. A
new audit trail file is automatically created each month and placed in the Kaye Validator AVS
application folder.
When running the Kaye Validator AVS in standalone mode, each Kaye Validator AVS maintains
its own audit trail events which identifies the type of action performed, the date and time the
action occurred, and any additional information required to understand the action taken. The
program extracts the Kaye Validator AVS audit trail events when the program establishes
communication with the Kaye Validator AVS. Each event is appended with the name of the
responsible operator and added to the audit trail of the Console.
Audit trail data is available to authorized personnel through the Audit trail tile. The
System Administrator can:
• View and print the audit trail
Table 3 below includes a list of system and user-defined audit trail events.