Change control for computer related systems

Validation of computer related systems - whether it is prospective validation cause of system development or retrospective validation of legacy systems - usually requires an essential amount of money and personnel ressources. Once validated, computer related systems are in permanent change, on the one hand due to technology advancement, on the other hand due to internal optimizations. Computer related systems in the pharmaceutical production and quality control are based in a highly sensitive and regulated environment. This requires adequate procedures to monitor and control any system changes to ensure that all users and IT experts pull together and that the validity of the system is guaranteed.