Metrohm tiamo 2.2 (ProcessLab) - Manual (Page 1254)

6.2 Administration ￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭
1238 ￭￭￭￭￭￭￭￭ tiamo 2.2 (ProcessLab)
6.2.2.4 Audit Trail/Modifications
Tab: Configuration ▶ Tools ▶ Security settings ▶ Audit Trail/Modifications
Audit Trail recording is enabled and disabled on the Audit Trail/Modifi-
cations tab. When a method, determination or sample data is modified,
you can also define whether or not a reason must be given for the modifi-
cation together with comments.
Settings according to 21 CFR 11
[Set]
Sets the parameters to default settings for FDA-compliant work.
Audit Trail
Enable Audit Trail
If this check box is activated then all program actions will be automatically
recorded; these are defined as Audit Trail actions.
Selection on | off
Default value off
FDA default: on
Modifications
Comment on modification of methods
If this check box is activated then each time that a method is modified a
modification reason and a modification comment must be entered; these
are saved in the method and shown in the method history. The reason and
comments are also recorded in the Audit Trail.
Selection on | off
Default value off
FDA default: on
Comment on modification of determinations
If this check box is activated then each time that a determination is modified
a modification reason and a modification comment must be entered; these
are saved in the determination and shown in the database in the subwindow
Information on the tab Determination. The reason and comments are
also recorded in the Audit Trail.
Selection on | off
Default value off
FDA default: on