Traditionally GAMP has advocated a computerized system validation framework to achieve and maintain GxP compliance throughout the computerized system life cycle. Where subsequent process validation or continuous quality verification of the overall process or system can apply. 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 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:
process control and process analytical,.A broad range of systems including, but not limited to –