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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.
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.
Minimized project risks
V-Modell^® XT projects are implemented in project sections. A project must pass a set of decision gates to progress through these sections, which is possible only if specific criteria are met. Project roles describe a set of tasks and responsibilities within the project and are assigned independently from the organizational structure.

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.
    - Standardized project setup
      Concepts and components of V-Modell® XT projects are well-documented and known to all project participants, supporting clear project communication.
    - Minimized project risks
      V-Modell^® XT projects are implemented in project sections. A project must pass a set of decision gates to progress through these sections, which is possible only if specific criteria are met. Project roles describe a set of tasks and responsibilities within the project and are assigned independently from the organizational structure.
    - Guaranteed quality
      By describing the expected results and allowing for interim quality checks, the V-Modell^® XT process model ensures that the provided results are complete and have the desired quality.
  - 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).
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.

Minimized project risks

V-Modell^® XT projects are implemented in project sections. A project must pass a set of decision gates to progress through these sections, which is possible only if specific criteria are met. Project roles describe a set of tasks and responsibilities within the project and are assigned independently from the organizational structure.

Stegmann Systems employs a standardized project execution strategy, depicting the decision gates required for a project and the sequence in which the gates must be passed. Stegmann Systems employees holding the required project role verify that the gate-specific criteria are met and confirm the progression of the project.

The following figure shows the project execution strategy employed by Stegmann Systems:

Project execution strategy of a V-Modell® XT project at Stegmann Systems — Figure 1. Project execution strategy of a V-Modell^® XT project at Stegmann Systems