An Example:
AMCS' ESG provided a prospective turnkey Control System design, development, and validation of a new 1500 ton / day bulk medical gas manufacturing process / facility. Activities included design and development of the facility's integrated control system, reviews and updating of facility P&ID's to reflect "as-built" instrumentation, new process equipment, and controls, validation of the facility Control and physical process systems.
Specific Control system activities included the acquisition and installation of the computerized control systems, development of Design & Functional specifications, software assessments, code development and programming, code & program testing under normal & stressed conditions, hardware and software installation, and system integration testing.
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.
