ABSTRACT

In Chapter 20, we learned that validation is commonly understood to mean: “The establishment of evidence that a computer system does what it purports to do and will continue to do so in the future.” The process of validating a system involves defining what the system purports to do, establishing evidence that it is doing that, and then providing assurance that it will continue to work correctly in the future. Modifying a system may change what it purports to do, which will leave it in a state of having no evidence that it is still doing what it is supposed to do. Change control provides the framework for ongoing documentation of what the system should do and providing evidence that it does do it. The change control process, or change management process, as it is sometimes called, process involves documenting needed changes, implementing the changes, and testing the impact of the change.