Data Sheet for Product

Technical Specification Sheet
Document No. 149-988
January 10, 2014
Document No. 149-988 Page 1 of 3
Compliance Support Option for Insight
Description
The Compliance Support Option for Insight

provides functionality for detailed tracking of
modifications and deletions of supervised objects. With
this option, you can track which property of an object
was changed, its value before and after the change,
who made the change, why the change was made,
who authorized the change, and from where the
change was made. This is particularly beneficial for
facilities that are required to comply with the Food and
Drug Administration (FDA) regulations for Electronic
Records, or 21 CFR Part 11.
Main features of the Compliance Support Option are:
• Supervised Objects (points, PPCL, Trend
Collection Reports, User Accounts, and field
panel )
• Enhanced Operator Action Logging and Audit
Trails using the System Activity Log
Supervised Objects
A supervised object is a point, Trend Collection report,
user account, field panel on a dedicated BLN in
System Profile, or PPCL program that presents an
additional warning that may require a user password
and/or a supervisor password in order to be modified
or deleted. This protects against inadvertent changes
damaging critical system functions, as well as enabling
enhanced logging on objects to provide audit trails.
When making a change, users are required to enter
the reason for the change and then depending on how
the object is set up, users attempting to edit/delete the
object are either warned and allowed to continue, or
are warned and required to re-enter their user
password and/or have a supervisor enter a password
to continue.
Figure 1. Supervised Object Set Up.