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.
This topic highlights key features of the PLA 3.0 software.
Extensibility
PLA 3.0 consists of a framework and add-ons. The PLA 3.0 framework handles data as electronic documents. It provides the features you need to achieve regulatory compliance such as access control, data integrity, security, validation, and traceability. PLA 3.0 add-ons extend the functionality of the PLA 3.0 framework to include the analytical methods your users require and enable them to visualize, document, and report results.
For details on the extensibility feature, see the Extensibility with add-ons topic.
Method life cycle support
Functional administrators use documents to develop analytical methods in a test environment, and create templates for finalized methods. Quality assurance inspectors apply electronic signatures to templates to approve the developed methods and confirm that they are suitable for the intended use. In the production system, users create documents based on the provided templates, thus implementing the related method. To distribute results, they create reports.
For details on documents and templates, see the Documents and Templates topics.
Continuous improvement
Each new version of PLA 3.0 introduces new major capabilities. The framework receives comprehensive features and refined functions, add-ons introduce new analytical options to comply with the latest methods.
For details on individual features and functions, see the What's new in PLA 3.0? topic.