Test Scripts under GAMP a burden?

After another successful qualification test to deploy additional functions to an existing category 4 system, the use of Test Scripts is optimized to a stage of helpful rather than tiresome, as the original feeling most people might recognize when they start working with GAMP. Key is to integrate a Test Script in the whole process by starting to write them from the very first initial phase. In a fact this is almost parallel to the development iterations in an agile approach. Doing so helps to improve not only your requirements, but also to support developers in building the software functions.

One tends to start thinking about testing when development is ready or about to end. The big hurdle of validation and qualification including testing might cause some deep breaths before you start with it. But there is no need to.

From writing the Test Script alongside the software development, it will become clear where the gaps are in software functions. By starting during the system development you force yourself - as Project Manager - to a focus towards the outcome of a software development track (user related) above a focus on the development finalization (deliverable related). Using draft Test Scripts in your own checks towards your developers or suppliers increases the quality of the software you deliver.

There is also a huge benefit regarding the project or development completion time. Writing your Test Script in parallel prevents a separate, time consuming step to take after software development stages.

On top of this all there is a benefit in making users understand the relevance of thorough testing and to make them more aware of the level of requirements needed. This might help in transferring the next wish into a clear request and a feasible design of additional functions.

Regarding Test Scripts I'd say: don't hesitate, just integrate.