An Example:
AMCS' ESG prospectively develop & validate a control system replacement for an existing 200 TPD medical gas manufacturing process / facility. Activities included the design & development, acquisition and installation of a control system that would integrate to existing physical processes and equipment, removal of the existing facility control system, commissioning and validation of the revised control system and start-up services to optimize operating conditions using the revised system.
Additional activities included the completion of documentation "packages" that provided accurate and complete P&ID's for the control strategy, instrumentation and wiring diagrams, interlocks and logic diagrams. Validation activities included the development of a Validation Master Plan & protocols to provide compliant validation to 21 CFR 11, 210, 211 (Electronic Record-keeping & Signatures, Process Validations) followed by on-site execution of the protocols, and completion of permanent documentation for compliance files.
