PLA is a commercial off-the-shelf software solution for analyzing biological assays. Various properties allow you to define the flow of calculations. Regardless of the selected settings you will never leave the verified range of calculations. The selection of these options is "use of the software" making PLA a level 3 solution in terms of GAMP.
In PLA there is no programming of protocols or corresponding tasks which have to be considered as level 5 solutions, and requiring huge efforts to validate these protocols.
But even as a level 3 solution, GAMP requires some validation efforts from your side. The PLA Validation Package is there to help you with that. This PLA Validation Package is an addon, which you can purchase separately. It enables a number of features in the software, making it easy to qualify your systems.