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. Read more.
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. Read more.
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.