UCB Manufacturing, Rochester, NY

Vertical market: Pharmaceutical

Project Summary:
The project consisted of the replacement of a proprietary BAS system with a web-based open-protocol SCADA system with FDA 21 CFR Part 11 compliance.

Project Details:
O&M Engineering, Inc.’s (O&M) first phase of the project was to replace the current proprietary supervisory controllers with web-based supervisors.  This entailed integrating all of the existing I/O from the field controllers, as well as converting the control logic, to ensure all existing processes continued to function correctly.

The next phase of the project was to create a PC-based front-end for the maintenance personnel to view their system.  To accomplish this, O&M integrated the web-based supervisory controller I/O to the PC located in the maintenance office.  O&M continued to build on this framework to implement the FDA-compliant installation.  The basis for this system was a web-based SCADA system that was 21CFR11-compliant. The SCADA system was loaded on a customer-supplied server-class machine, running Microsoft Windows 2003 Server.  Microsoft SQL 2005 was also installed on the server, to enable historical (trend) data collection, as well as Alarm and Event (A&E) data collection.

To comply with the FDA regulations, O&M setup the A&E data collection to record operator control change audit trails, as well as recording operator comments, both for reporting needs. Also part of the 21CFR11 compliance, O&M setup trending of the I/O points, all logged to a SQL database.  This data was then used to produce daily, weekly, and monthly reports.

Lastly, one very important requirement of 21CFR11 compliance is access control.  O&M was able to implement a very stringent security program to restrict user access to any part of the SCADA system.  This was applied on both an application- and function-specific role, as well as on a per-file basis.  This security implementation resulted in personnel being granted access only to perform their duties, as well as meet the FDA 21CFR11 accountability and tracking requirements.