Execute controlled testing of your application to achieve validation.
Meet Jim, who works in the Quality organisation at PharmCo. Jim needs to ensure that his GxP documentation is managed in a controlled way.
Dave works in IT and is responsible for providing a solution to Jim that meets his requirements.
Dawn from the Compliance Team needs to ensure that the process followed by Dave is compliant and that the system that he uses for managing his documentation is validated
Computer System Validation (CSV)
The process used to ensure (and document) that a computer-based system will produce information or data that meets a set of predefined requirements. If a system meets these requirements, it can be assumed that it is consistently performing in the way it was intended.
.