Stelex and Yokogawa published 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.
Part 11, a regulation issued by the Food and Drug Administration (FDA) in August, 1997 , provides criteria for the acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper.
Part 11 applies to any records required by FDA statute or regulations which are kept electronically, such as batch records. Computer systems subject to Part 11 must be validated, this requirement satisfied by employing the SDLC (System Development Life Cycle) methodology utilized by most companies.
CENTUM VP is a production control system designed for the control of pharmaceutical process-oriented plants, including intelligent instrumentation, analyzers, electronic recorders, distributed control systems, and plant information management systems.
The paper explains how CENTUM VP can be used to help users comply with Part 11. Yokogawa retained Stelex to assess and evaluate its latest CENTUM VP system. Stelex previously authored a white paper for Yokogawa”s prior DCS version, the CENTUM CS 3000 R3. Yokogawa and Stelex have also collaborated on Part 11 white papers and the design of DAQSTATION network solutions recorder products and the Exaquantum/Batch batch plant information management system, all of which are part of Yokogawa’s pharmaceutical industry solutions.
To download a copy of the Yokogawa/Stelex paper, click here.