Specifications

Audit-trail details for valida-
tion and default validation
audit-trail
The validation and default valida-
tion audit-trails display all actions
that are related to a validation
database.
Both audit-trails offer the follow-
ing information where each item
displays its data in a separate col-
umn:
• Date and time of action
• User ID and
• Printed user name
• Level of action ( e.g. level 4 for
configuration changes)
• Status of the change ( saved
or unsaved
• Component
• Checkpoint
• Action (the audit-trail lists the
menu if the user did only open
the menu without changes and
it lists any parameter change
with the old and the new value)
• Authentication (for all actions
that require an electronic
signature)
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Audit-trails
Method Validation Pack audit-trail
tracks all actions that users exe-
cute during program operation.
The audit-trail is user-independent,
can not be modified and it is com-
pletely system generated. Method
Validation Pack has three different
audit-trail levels, as shown in fig-
ure 41:
• program audit-trail,
• default validation audit-trail,
and
• validation audit-trail.
The default display size of the
audit-trail can be configured in the
audit-trail window. The number of
entries for display must be
between 25 and 30000.
For easier searching through the
audit trail, users can group the
audit-trail entries. All audit-trail
column headers are available as
grouping criteria. The grouping
functionality uses a simple drag-
and-drop functionality to enable
or disable grouping. The user only
drags the column header into the
grouping section and receives a
sorting of the complete audit-trail
according to the column entries.
As an example, the audit-trail
should be arranged by user name.
The system displays all user name
entries as parent nodes. A simple
click on the expand icon now dis-
plays all audit-trail entries for the
selected user as shown in figure
42.
Figure 41
Three levels of audit-trail with Method Validation Pack software