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Regulatory compliance
PLA 3.0 supports you in achieving compliance with regulations such as ISPE GAMP^® 5 and 21 CFR Part 11. It also provides options to validate PLA 3.0 in your environment.
Validation
Achieving compliance with ISPE GAMP^® 5 requires software to be validated in the target environment. Stegmann Systems supports the validation of PLA 3.0 in the target environment through the PLA 3.0 Validation Package, which provides fully automated functions for Installation Qualification (IQ) and Operational Qualification (OQ).

Get started
Explore PLA 3.0, its key features and ongoing enhancements, and learn how to log in and register.
User interface
PLA 3.0 supports you in your daily work by providing a set of graphical and textual user interface elements. Learn about the different elements and how to use them efficiently.
Key concepts
Details on documents and templates, the data editors and the Content editor of PLA 3.0. Learn about the position factors and data aggregation features.
Data analysis
Data analysis add-ons offer a wide range of capabilities, ranging from analytical methods over comprehensive analysis to statistical process control. PLA 3.0 also provides a set of add-ons that support and supplement data analysis add-ons.
Data import
Use data acquisition and data import add-ons to import external response values and observation data into PLA 3.0 for further processing and evaluation.
Installation
Details on the deployment, installation, initial and advanced setup of PLA 3.0.
Licensing
Details on the licensing solution of PLA 3.0, the available licensing options, and the activation and management of licenses.
Administration
Details on system administration tasks such as setup and maintenance of databases and add-ons, user accounts, access rights, and migration and update procedures.
Regulatory compliance
PLA 3.0 supports you in achieving compliance with regulations such as ISPE GAMP^® 5 and 21 CFR Part 11. It also provides options to validate PLA 3.0 in your environment.
- Integrity
  Data integrity refers to the completeness, accuracy, and consistency of data over its entire life cycle. PLA 3.0 stores all your data in electronic documents, which are in turn stored in a database. When handling documents, PLA 3.0 utilizes digital signatures to ensure that documents are not tampered with.
- Authenticity
  Authenticity of digital data verifies that data is genuine and comes from its purported source. In PLA 3.0, users can employ electronic signatures to protect complete documents, document structures, and document data. Administrators can configure the handling of electronic signatures such that it supports regulatory compliance.
- Confidentiality
  Data confidentiality ensures that data is protected from unauthorized access and disclosure, and that personal privacy and proprietary information is protected.
- Traceability
  Traceability ensures logical data integrity, that is, you can trace your data across your entire system, from its current status back to its original source. In PLA 3.0, you can require users to specify why they modify documents and protected values to improve traceability and protect data from intentional and unintentional changes.
- Validation
  Achieving compliance with ISPE GAMP^® 5 requires software to be validated in the target environment. Stegmann Systems supports the validation of PLA 3.0 in the target environment through the PLA 3.0 Validation Package, which provides fully automated functions for Installation Qualification (IQ) and Operational Qualification (OQ).
  - Installation Qualification
    The Installation Qualification process (IQ process) of the PLA 3.0 Validation Package checks the completeness and correctness of the PLA 3.0 installation.
  - Operational Qualification
    The Operational Qualification process (OQ process) of the PLA 3.0 Validation Package verifies the correctness of mathematical calculations performed by PLA 3.0 on the target system, using datasets verified by Stegmann Systems.
  - Performance Qualification
    The Performance Qualification process (PQ process) of the PLA 3.0 Validation Package verifies the correctness of mathematical calculations performed by PLA 3.0 on the target systems, using datasets verified by the customer.
- 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.
PDF downloads
Download PDF guides of current and previous framework and add-on versions.
Sample lab
Meet the team at Stegmann Labs, where PLA 3.0 plays an essential role in every step of bioassay management.
Glossary
Find definitions of terms.

PLA 3.0 Validation Package

Achieving compliance with ISPE GAMP^® 5 requires software to be validated in the target environment. Stegmann Systems supports the validation of PLA 3.0 in the target environment through the PLA 3.0 Validation Package, which provides fully automated functions for Installation Qualification (IQ) and Operational Qualification (OQ).

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.

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

Validation coverage

The IQ process of the PLA 3.0 Validation Package validates the complete installation of PLA 3.0. The OQ process validates data analysis add-ons regarding their mathematical correctness.

Figure 1. Areas validated during the IQ and OQ processes of the PLA 3.0 Validation Package

Note: The PLA 3.0 Validation Package does not cover Design Qualification (DQ) where requirements are defined to prove the system is suitable for the intended purpose.

Installation

The qualification functions of the PLA 3.0 Validation Package are delivered as a part of the PLA 3.0 framework and do not require a separate installation.

You can access them from the Validation menu in the PLA 3.0 menu bar:

Validation menu in the PLA 3.0 menu bar — Figure 2. Validation menu in the PLA 3.0 menu bar

Important: The PLA 3.0 user executing the validation needs the task permission corresponding to the qualification process, usually associated with an administrative global role.