Basic concepts

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.

The following list highlights the basic concepts you should be familiar with when working with PLA 3.0:

  • Electronic documents
  • Templates
  • Modularity of the system

Electronic documents

Electronic documents store your data

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. The full set of elements creates the document structure. To give you greater flexibility, documents are organized in folders where several restrictions can be applied (permissions, privileges, mandatory templates).

 

When the work on your document is finished, you can sign it to prevent further change. Electronic signatures in PLA 3.0 are compliant with 21 CFR part 11. To learn more about how to work with documents and folders, please go to 'Support & Learning'.

Templates

Templates support your method lifecycle

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.

Set initial values and use protection settings to fine-tune your document setup regarding the visibility of elements, or the possibility to add, edit, or delete elements.

 

Use templates to implement your Standard Operation Procedures and prevent changes to the template setup by signing the template. To learn more about how to work with document templates, please go to 'Support & Learning'.

Modularity

Modularity allows for easy extendability

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.

 

The framework and its add-ons can be updated independently. To learn more about how to work with the framework and its add-ons, please go to 'Support & Learning'.