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- March, 2011
Tips of the Month
March, 2011
Audito Trails Function of the Paperless Recorders DXAdvanced
The DXAdvanced R4 (hereinafter, DXAdvanced) optional enhanced security function (/AS1) supports the US FDA's(*1) 21 CFR Part 11(*2).
For electronic recording, 21 CFR Part 11 requires audit trails, strict security, data management, and electronic signatures.
(*1) FDA: Food and Drug Administration
(*2) 21 CFR Part 11: guidelines on electronic recording and electronic signatures
This document describes the DXAdvanced's support for audit trails.
Audit trail
A record of the date, time, and description of an operator creating, editing, or deleting an electronic recording.
DXAdvanced Audit Trail Function
On the DXAdvanced, a history of all alarm output, alarm confirmations, error messages, main unit setting changes, and other operations is automatically recorded and saved along with measured data files. This recorded logs of settings changes and operations can be viewed on the DXAdvanced main unit or DAQSTANDARD software.
Fig. 1 DXAdvanced Operation Log Screen
In addition to an audit trail, the DXAdvanced also supports the security, data management, and electronic signature requirements of 21 CFR Part 11.
For details on this support, please see the Technical Information document,
"DAQSTATION DXAdvanced Advanced Security Function White Paper for FDA 21 CFR Part 11 (TI04L41B01-03E)."
