Audit Trail Report - Kaye Validator AVS User Manual

11.5. Audit Trail Report

To meet 21 CFR Part 11 and Data Integrity requirements, the Validator AVS system
includes a robust and comprehensive Audit Trail.
The Audited Trail automatically captures all system and Operator actions which affect
the creation, modification, deletion, or storage of GXP data and reports.
The purpose of the Audit Trail is to give Users the ability to review and print the history
of actions affecting Gxp files and events.
The Audit Trail is automatically generated and stored in monthly encrypted files which
are protected from User access or modification. Integrity checks are performed before
any data is written to the current monthly file and a backup of the monthly file is
captured each time the Validator AVS software is started.
Actions which are captured include:

User actions requiring a login with a User ID and Password.

Automated system actions or events.

Any additional actions deemed critical to the history of the data or
Qualification files.

To access the Audit Trail, navigate to the Validator AVS Software Main
screen and select Audit.
The Audit Trail contains a complete history of the system. The entries include:

User ID and Name of Operator initiating the action.

Date and time the action was taken.

Description of action taken. If action was to change value description
includes original value and well as new value.
Kaye Validator AVS User Manual
Figure 95: Audit Trail
Chapter 11: Qualification Reports
139