The procedures for the development and implementation of IT systems have changed dramatically in recent years. Whereas previously the requirements were recorded in detail at the start of the project and then executed step by step, the complexity of systems and projects makes today’s stage-oriented approach too inflexible, as it does not allow for a variation or adjustment of defined measures. Therefore today so-called “agile methods” such as SCRUM are used as an alternative to the waterfall-oriented models. Agile methods allow the successive expansion and modification of the requirements in iterative steps
Computer System Validation (CSV) also has to deal with this issue because the now widely used and established V-model is based on the non-iterative waterfall model. It cannot therefore be used for agile approaches to validation. For the first time ever, the current GAMP 5 allows for a departure from the classic V-model and therefore the use of agile, scalable methods. Using this procedure, the prospective validation can continuously accompany the IT project.