We deliver PLA 3.0 as a verified software system. The PLA Validation Package automates several tasks in the validation process on the target computer system.
According to GAMP regulations, the customer - not the vendor - is responsible for validating the software. This means, you have to validate PLA 3.0 on your computer system, in order to meet GAMP regulations. To help you minimize the required validation effort, we created the PLA Validation Package.
The PLA 3.0 Validation Package is an add-on that provides the features to qualify your PLA 3.0 software on your target computer system, compliant with GAMP. It contains functions for automatic installation and operational qualification (IQ and OQ) and supports your performance qualification (PQ).
The OQ data set for the Biological Assay Package includes several hundred datasets that can be run with the OQ functionality. The results of these calculations are then compared to digitally signed data sets.