This environment requires both complete product and process understanding and that the critical process parameters can be accurately and reliably predicted and controlled over the design space. Where a computer system is regarded as one component of a wider manufacturing process or system, particularly in integrated quality by design environment, specific and separate computerized system validation may not be necessary. the application of appropriate operational controls throughout the life cycle of the system.the adoption of principles, approaches, and life cycle activities within the framework of validation plans and reports.The computerized system consists of hardware, software, and network components, together with the controlled functions and associated documentation.Īchieving and maintaining compliance with applicable GxP regulations and fitness for intended use by: vigilance and document management systems.
A broad range of systems including, but not limited to –
