Quality governance

Quality governance ensures a structured approach to maintaining and improving quality within Stegmann Systems. It covers the principles, processes, and verification steps we apply to achieve compliance, reliability, and continuous improvement in our development and validation practices.

About PLA 3.0

PLA 3.0 is a commercial off-the-shelf software for biostatistical analysis in Research and Development (R&D) and regulated environments. It provides a range of features you can use during the design and implementation of analytical methods and also supports you in achieving regulatory compliance.

As PLA 3.0 is non-configurable and calculations are always performed within the verified space, it can be categorized as an ISPE GAMP® 5 category 3 solution. This document describes the concepts utilized by Stegmann Systems in this context.

Verification and Validation of PLA 3.0

Achieving compliance with ISPE GAMP® 5 requires software to be validated in the target environment. Validation of PLA 3.0, therefore, happens after delivery on the customer side as part of the Installation and Validation process.

Verification of PLA 3.0, on the other hand, happens at Stegmann Systems as part of the Development and Verification process. The following figure shows the dependency between these processes:
Figure 1. Dependency between the Development and Verification and Installation and Validation processes

Development and Verification

The Development and Verification process at Stegmann Systems employs the V-Modell® XT software development process model. Adherence to this model ensures strict quality assurance and thorough testing before delivery.

PLA 3.0 is a modular software. The underlying framework is responsible for the integrity and reliability of measurement data and provides security features. It comes equipped with protected installation reference data. Add-ons provide extensions for biostatistical analysis and data acquisition and come equipped with their own protected installation reference data. Data analysis add-ons additionally come equipped with protected operational reference data.

Installation and Validation

To support customers during the validation process, Stegmann Systems offers the PLA 3.0 Validation Package. Customers with a license for this package can use the protected reference data for validating PLA 3.0 in the target environment, employing the Installation Qualification and Operational Qualification processes provided by the package. Both processes are fully automated.

  • The Installation Qualification (IQ) process compares the installation reference data with the PLA 3.0 component files installed in the target environment.

  • The Operational Qualification (OQ) process compares the operational reference data with the calculation results obtained by PLA 3.0 in the target environment.

Note: The PLA 3.0 Validation Package also provides a semi-automated Performance Qualification (PQ) process. This PQ process allows customers to use their own verified datasets for validating calculation results of further in-house PLA 3.0 installations or, for example, PLA 3.0 installations at a Contract Research Organization.