Validation as we know it is DEAD. Manual, paper-based processes hinder productivity and efficiency throughout the validation process. The pillars of lean validation are the elimination of wasteful validation processes, minimizing risk, optimizing the validation process, driving efficiency and quality and ensuring sustained compliance. None of these pillars can be achieved without automation.
Lean validation requires automation to eliminate wasteful processes. Establishing, tracking and managing user requirements on paper is an arduous process. To track requirements on a granular level is difficult on paper. Automation can help drive greater efficiency and compliance. Creating and executing test scripts is one of the most time-consuming validation tasks yet many companies still conduct validation testing on paper. It is clear that the more an application is tested the greater the chance of revealing an error. However, it is not practical using manual means to conduct testing sufficient for complex applications without expending significant effort to do so. Automation is essential to drive this process.