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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.
PLA 3.0 Validation Package
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.
Certificate of Qualification
In the case of a successfully executed PQ, the first page of the report shows the Certificate of Qualification.

Get started
Explore PLA 3.0, its key features and ongoing enhancements. Learn how it fits into your environment, and 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.
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 and installation of licensed PLA 3.0 versions.
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.
  - 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.
  - Installation and Validation
    On the customer side, PLA 3.0 is installed in the target environment and validated to achieve compliance with ISPE GAMP^® 5.
  - PLA 3.0 Validation Package
    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.
      - 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.
PDF downloads
Download PDF guides of current and previous framework and add-on versions.
Sample lab
Meet the team of Stegmann Labs Inc. and use our sample laboratory to explore core features and functions of PLA 3.0.
Glossary
Find definitions of terms.

Certificate of Qualification

In the case of a successfully executed PQ, the first page of the report shows the Certificate of Qualification.

The certificate shows the following information:

Date and time on which the qualification was performed
User who performed the qualification
Name of the computer that was qualified
PLA 3.0 serial number and version
Database name and Universally Unique Identifier (UUID)