Applied Sciences Group, Inc.

Applied Sciences Group (ASG) was contracted by a medical manufacturer that produces slides for medical diagnostics. The slides have a proprietary coating placed on a substrate film material. Processes at the facility include formulation (batch processing), coating (continuous web processing), slitting and chopping (packaging). The entire process must comply with 21 CFR Part 11 for any records it chooses to store electronically about products produced at the facility. This traceability is highly regulated. Records were stored electronically on disparate systems provided by the various equipment OEMs however this facility needed to comply withstandard FDA regulations and Good Manufacturing Practices (cGMP).

ASG was able to leverage a combination of “off –the-shelf”, cutting edge software from GE Intelligent Platforms along with custom software application development to meet the challenges and requirements of the project. ASG was contracted to integrate a server-based system to support the needs of production, quality systems, and engineering personnel. The system is comprised of a high-availability computing environment with three servers. One is dedicated to a 3,500 tag GE Proficy Historian, the second is an unlimited tag GE Proficy iFIX SCADA, and the third a Proficy Real-Time Information Portal Server. ASG and our customer functioned on a joint, coordinated project team and implemented a progressive action plan to replace the disparate data collection systems that were the result of several different OEM installations, by translating the old historical files to a usable format. An example was in the coating area which was controlled by a sophisticated, but out-dated, DCS made by Westinghouse and installed in the late 1970’s. The data historian used by this system utilized a format that is not compliant with contemporary data collection historians (such as the OPC-compliant GE Proficy Historian) or the regulation requirements for 21 CFR Part 11. As such, ASG was contracted to reverse engineer the WDPF historian files, migrate 5-years of data and provide a connection to the Proficy Historian server. It was imperative that 7 years of contiguous historical data be available to comply with the regulations of 21 CFR Part 11.

Additional action plans that have been implemented over the years by the joint project team include:

• A winder system was also upgraded to provide connection to the Proficy Historian.

o GE Proficy (iFIX, Historian, Real Time Information Portal)

o Allen-Bradley PLCs (ControlLogix, MicroLogix, PLC5)

o Siemens PLC’s (S7 300)

o National Instruments (Labview)

Applied Sciences Group is under contract to develop a Cardiac Monitoring System (CMS) using a dual balloon esophageal catheter to measure cardiac performance. A medically trained operator inserts the catheter through the nose into the esophagus, and uses an Electronics Unit (EU) attached to the catheter to position and inflate the balloons behind the left atrium and aorta. Pressure, audio and ECG measurements are taken and physiological parameters are derived from them. The project was a group effort between four corporate teams with specific skill sets to contribute to the product development process. Although the teams were separated geographically, coordination of many of the tasks was completed with little difficulty and in a timely manner.

Applied Sciences Group, Inc. (ASG) was responsible for the daily planning and software management of the project. The assigned project manager coordinated the technical efforts, provided the systems engineering inputs, initiated staffing requests and provided regular and timely communications between the teams. The engineering team contributed to the requirements specification and risk analysis, and provided the software architecture design as well as the detailed software design, coding and documentation. ASG was also responsible for quality control oversight that included support on FDA regulatory issues: including identification and implementation of appropriate standards and formal compliance testing.

The CMS relies on significant mathematical analysis and to isolate the signals of interest from interference due to respiration, peristalsis and other contributions to pressure noise. ASG was responsible for the development and tuning of all algorithms to accommodate a broad range of patient physique and size, and to provide reliable, accurate results. ASG also provided guidance to overall system design and led the design of the user interface. As a part of the overall development, ASG employed a controlled methodology to establish a verification plan and validation procedures to demonstrate that the design met the defined requirements. This process, consistent with FDA regulatory requirements, is intended to provide quality software development across all projects.