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.
The installation qualification routines of PLA 3.0 verify all system components and deliver a certificate as well as a detailed report about the installation on the target system. It certifies that all required components are in place, which basically means that all the files have been copied to your computer correctly. In case your hardware is damaged and PLA could not be installed correctly, the installation qualification would fail and you would get a report stating the error.
Note: Although the Installation Qualification is part of the Validation Package, it does work in the trial version of PLA as well, but only for demonstration purposes. You cannot print the resulting certificate.
The operational qualification is able to validate the calculation routines of a PLA 3.0 document. The OQ data is delivered with the package. You need a Validation Package license to use the OQ data for qualifying a system.
The OQ data set for the biological assay package contains several hundred datasets that can be run with the OQ functionality of PLA 3.0. The results of these calculations are compared to digitally signed data sets delivered with the document package. After the successful verification, the program creates a certificate.
The performance qualification requires customer data to be verified. PLA allows you to create your own verified data sets. You can use these data sets for the automated qualification of additional computer systems and for the re-qualification after changes in the environment or when you updated PLA 3.0.
If you work in a regulated environment and would like to save time and effort in validating the software then the PLA Validation Package is the right choice for you. Please contact our support team for a quote.