Chapter
11: Qualification Reports
Kaye ValProbe RT User Manual
108
11.5. Audit Trail Report
To meet 21 CFR Part 11 and Data Integrity requirements, the ValProbe RT 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 stored in an encrypted file and protected from User access. The data in the
Audit Trail cannot be deleted and or modified.
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 ValProbe RT Software Main screen and select Audit.
Figure 119: Audit Trail
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
•
User comments entered when action was taken
•
ValProbe RT hardware serial number of units affected
•
ValProbe RT Console Machine ID to identify from which Console action was initiated
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