A Computer is a functional unit that can perform substantial computations, including numerous arithmetic operations and logic operations without human intervention.
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A Computer is a functional unit that can perform substantial computations, including numerous arithmetic operations and logic operations without human intervention.
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A Computerized System is 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.
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Computerized system validation describes achieving and maintaining compliance with applicable GxP and Medical Device regulations and establishing documented evidence that the system is fit for intended use by:
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A Computersystem is a system containing one or more computers (or hardware components) and associated software.
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