PLA 3.0 is a software for biostatistical analysis in Research and Development (R&D) and regulated environments. It is designed for biopharmaceutical and regulated industries and covers the whole lifecycle of the analytical procedure for your pharmaceutical product, from early development to production.
PLA 3.0 supports all types of biological potency assays according to European Pharmacopoeia chapter 5.3 and U.S. Pharmacopeia <111>, <1032>, <1033>, <1034>. Besides, PLA 3.0 supports interpolation and spike-and-recovery analysis as well as EC 50 calculation. For details on all supported methods, please have a look at our 'Analytical Methods'.
Key features of PLA 3.0 include:
Method lifecycle support. PLA 3.0 supports your method life cycle from early stages to development and operation. Develop your methods using documents. Implement your methods by saving your documents as templates.
Electronic documents. In PLA 3.0, all your data is stored in electronic documents. Documents are optimized for handling complex data structures. Each document contains a set of elements, with each element holding specific data.
Modularity. The PLA 3.0 framework is responsible for the integrity and reliability of measurement data. It provides security features employing user accounts, roles, and permissions. It also offers strong validation features for Installation Qualification and Operational Qualification. PLA 3.0 add-ons allow you to easily extend your work environment with new features. They provide extensions such as document types, report templates, data acquisition modules, and customer-specific modules.
With PLA 3.0.5 we introduce a new add-on: The Dose-Response Analysis Package provides a range of additional biostatistical methods for immunoassays, ELISA, and more. It supports you in investigating equivalence for calibration curves and it provides enhanced data processing and analysis. New document reports and dashboards add to its value and usability.
PLA 3.0.5 always keeps you informed about new extensions and developments. You can easily customize your work environment to get the most out of your installation.
Customers who already work with PLA will notice numerous improvements that enhance performance and usability. Our efforts to improve your experience with PLA have streamlined workflows and eliminated redundant tasks.
PLA 3.0 supports your method life cycle from early stages to development and operation. Develop your methods using documents. Implement your methods using templates. Just save any document as a template and reuse its settings every time you select the template.
Implement your Standard Operation Procedures (SOPs) within PLA 3.0:
You are free to control the use of templates for every folder in the database. This allows you to set up a specific range of templates to be available for a specific project. Just set up all required templates and allow a project team to access a specific subset only.