ABSTRACT
As we saw in Chapter 20, one step in the system validation process is testing to provide evidence that the system behaves as it is expected to. For larger systems, such as clinical data management systems, this is a huge job. First, the scripts have to be developed. This can take months even if people are dedicated to the task. Then after the tests are ready, and the validation process has actually started, the scripts have to be run in the test environment. Because this is a critical point in the validation process, all eyes are on the testers and the test outcomes. The pressure is on because everyone is watching the timelines to move the system into production and stress levels rise every time a problem is encountered. From the practical point of view, no matter how much we talk about the validation process, the success and smooth implementation of a software application or system ride on the testing.
