PLA 3.0 Validation Package

Current version: 1.1, Release date: May 05, 2017

Abstract

The PLA 3.0 Validation Package supports you in the qualification of your PLA 3.0 software on your target computer system, compliant with GAMP guidelines.

It offers functions for the automatic Installation Qualification (IQ) and Operational Qualification (OQ). It also allows you to validate calculation results on PLA 3.0 workstations, using your own assay data (Performance Qualification, PQ).

The functions of the package are delivered as a part of the PLA 3.0 software and do not require a separate installation. They are available in the Validation menu of PLA 3.0.

To use the full scope of the package, you need a Validation Package license. Without the license, no certificates are generated and reports are generated with a watermark and cannot be printed.