For the validation of computerised systems there should be a system in place that assures the formal assessment and reporting of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement23. This should enable both the regulated user, and competent authority, to have a high level of confidence in the integrity of both the processes executed within the controlling computer system(s) and in those processes controlled by and/or linked to the computer system(s), within the prescribed operating environment(s)