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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).
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.
Preparation
Create and export a PQ definition document to prepare the Performance Qualification.

Get started
Explore PLA 3.0, its key features and ongoing enhancements, and learn how to log in and register.
Key concepts
Learn how the key concepts of PLA 3.0 form the structural foundation for your daily work, supporting method development from initial design to routine production.
Data analysis
Data analysis add-ons offer a wide range of capabilities, ranging from analytical methods over comprehensive analysis to assay workflows and statistical process control.
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.
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.
Installation and update
Details on deployment, installation, and update of PLA 3.0, and its initial and advanced setup.
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.
    - Procedure
      Performance Qualification with the PLA 3.0 Validation Package is a three-step process.
    - Preparation
      Create and export a PQ definition document to prepare the Performance Qualification.
      - Create a PQ definition document
        Create a PQ definition document with the dataset you want to use for verification.
      - Export PQ definition documents
        Export PQ definition documents as a PQ package and use their datasets to verify the mathematical calculations at your workstation.
    - Execute the PQ
      Execute the Performance Qualification to verify the correctness of mathematical calculations performed by PLA 3.0 at your workstation, using your datasets.
    - Certificate of Qualification
      In the case of a successfully executed PQ, the first page of the report shows the Certificate of Qualification.
- 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.

Preparation

Create and export a PQ definition document to prepare the Performance Qualification.

How-to video

The following video shows how you prepare the PQ in PLA 3.0: