Computerized System

The term computerized system covers a broad range of systems including, but not limited to, automated laboratory equipment, laboratory information management, clinical trials data management, vigilance systems, process control and process analytics, manufacturing resource planning, automated manufacturing equipment, manufacturing execution, and document management systems. The computerized system consists of the hardware, software, and network components, together with the controlled functions and associated processes, trained people, qualified equipment and specifications and records.

The computerized system is the regulated whole in the GAMP sense – and thus the object of validation: it is validated in its process context against its Intended Use, while components are qualified or verified.