ABSTRACT
Regulatory authorities expect that Supervisory Control and Data Acquisition (SCADA) systems are planned, developed, operated, and retired according to a life-cycle model that meets specific regulatory requirements. The goal of this case study is to assist professionals involved in any of the above life-cycle phases to understand the practical validation requirements for SCADA systems and how the various suppliers of these systems can satisfy these regulations. This case study is based on ANSI (References 110), FDA (References 11 and 12), and GAMP 4 (Reference 16) guidance. Supporting material has been taken from GAMP Forum’s Special Interest Group on Validation of process control systems (see Reference 17), the German GMA (Society for Measurement and Automatic Control) and NAMUR (Standardization Association for Measurement and Control), and the North American JETT Consortium (Joint Equipment Transition Team) looking at validation of the Skid Mounted Plant.
