Stelex and Yokogawa Corporation of America have completed a joint white paper discussing the use of Yokogawa's CENTUM CS 3000 R3 distributed control system (DCS) to meet the requirements of the Food and Drug Administration's 21 CFR Part 11.

CENTUM CS 3000 R3, commonly referred to as CS 3000, is a production control system designed for the control of pharmaceutical process-oriented plants. CS 3000 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 CS 3000 has been used in many validated pharmaceutical applications, including GAMP 4 projects, and has supported Part 11 for several years, we value Stelex's expert review and opinion on how CS 3000 can be used to comply with Part 11” said Bruce Jensen, Yokogawa Corporation of America's CS 3000 Systems Marketing Manager.

Chiaki Shimada, Yokogawa's Global Pharmaceutical Industry Marketing Manager said “the CS 3000 Part 11 whitepaper will further explain to the industry our approach to compliance for electronic records and electronic signatures. This white paper adds to the existing Stelex authored white papers for our DAQASTATION paperless recorders and Exaquantum/Batch batch Plant Information System products that are all parts of our pharmaceutical industry solutions.”

Yokogawa, a worldwide leader in process automation, retained Stelex to assess and evaluate their CS 3000 system. Yokogawa and Stelex have previously collaborated on Part 11 whitepapers and the design of DAQASTATION network solutions products and the Exaquantum/Batch batch plant information management system.

Daniel R. Matlis, Vice President of Business Development 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; we think this paper will be helpful to many organizations looking to implement the latest technology in a compliant manner.”

Roger Halliwell, Yokogawa's European Pharmaceutical Business Development Manager, agreed. “Stelex's guidance provided in the whitepaper provides additional assistance to the industry regarding best practices for using and validating CS 3000 in regulated applications.”

To download a copy of the white paper, please contact to CENTUM@csv.yokogawa.co.jp by E-mail.