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.
Installation Qualification (IQ)
PLA is able to qualify its correct installation. Just select the IQ process directly from the menu and PLA will certify your installation. Once completed you will receive a certificate.
Operational Qualification (OQ)
The Validation Packages comes with over 500 verified and documented datasets. These datasets are automatically calculated and verified on your systems to ensure that your results are identical to the validated ones. After executing this test you will receive a certificate from the system.
Performance Qualification (PQ)
Create comparison data on your own to verify other systems with your data. Once created you can easily qualify alternate systems.
If you are planning to use PLA 3.0 in a scenario in which you have to comply with GAMP regulations, please consider purchasing the PLA Validation Package. In virtually every case this additional investment more than pays for itself in terms of saved time and effort. Find out more about the PLA Validation Package.