April 18, 2010 - Stelex and Yokogawa have completed a joint white paper discussing the use of Yokogawa’s CENTUM VP distributed control system (DCS) to meet the requirements of the Food and Drug Administration’s 21 CFR § 11. CENTUM VP is a production control system designed for the control of pharmaceutical process-oriented plants. CENTUM VP is a key piece of Yokogawa’s global pharmaceutical solution offerings which includes intelligent instrumentation, analyzers, electronic recorders, distributed control systems, and plant information management systems.
“While CENTUM has been used in many validated pharmaceutical applications, including GAMP 5 projects, and has supported Part 11 for several years, we value Stelex’s expert review and opinion on how the current Yokogawa platform, CENTUM VP, can be used to help users comply with Part 11” said Bruce Jensen, Yokogawa Corporation of America’s Systems Marketing Manager. “Stelex’s guidance provided in the whitepaper provides additional assistance to the industry regarding best practices for using and validating CENTUM VP in regulated applications. “ Yokogawa retained Stelex to assess and evaluate their latest CENTUM VP system. Previously Stelex had authored a white paper for the previous DCS version, the CENTUM CS 3000 R3.
Yokogawa and Stelex have also collaborated on Part 11 whitepapers and the design of DAQSTATION network solutions recorder products and the Exaquantum/Batch batch plant information management system that are all parts of Yokogawa’s pharmaceutical industry solutions. Ken Keith, Vice President Sales and Marketing at Stelex said the joint project was a natural alliance. “We’re committed to helping regulated companies stay current with their compliance and technology needs; this paper will be helpful to many organizations looking to implement the latest technology in a compliant manner.”
About Stelex
For over twenty years, Stelex has provided enterprise-wide business solutions to regulated industries such as life sciences, manufacturing, transportation, energy and more. The firm offers a comprehensive suite of technology, validation, regulatory and business solutions. Stelex is a subsidiary of GE Healthcare (NYSE: GE).
About Yokogawa Corporation of America
Yokogawa Corporation of America, Corporation, is the North American division of $4 billion Yokogawa Electric Corporation, a global leader in the manufacture and supply of instrumentation, process control and automation solutions. Headquartered in Newnan, Georgia, Yokogawa Corporation of America offers a variety of clients with leading products on the market as analyzers, flowmeters, transmitters, controllers, recorders, data acquisition products, measuring instruments, distributed control systems, and more.
