An error has occurred. An error has occurred.
Results Profile

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.

UCB ManufacturingProject 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.

 

Expert Results

Expert ResultsPast performance is an accurate indicator of likely future results. Innovative Facility Solutions Experts have long and distinguished records of success solving some of the industry’s most perplexing problems, often under difficult circumstances. Testimonials from those who have experienced and benefitted from Innovative Facility Solutions member’s expertise and commitment confirm Innovative Facility Solutions as a wise choice.

Just ask, and we will be happy to provide project profiles, testimonials, and/or references most relevant to your specific opportunity.

 

 


Find Your Expert