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Data analysis
Analytical methods, comprehensive analysis, assay workflows, and statistical process control.
Suitability testing
Suitability testing ensures that assay results meet predefined performance criteria, confirming that the method is appropriate for its intended use.

Get started
Overview of the PLA 3.0 software, its ongoing improvements and version updates, and the available trial options.
Key concepts
Structural foundation for daily work and support for method development from initial design to routine production.
Data analysis
Analytical methods, comprehensive analysis, assay workflows, and statistical process control.
- Analytical methods
  Design potency assays, cylinder-plate and turbidimetric assays. Set up interpolation analysis, curve comparisons, and more.
- Suitability testing
  Suitability testing ensures that assay results meet predefined performance criteria, confirming that the method is appropriate for its intended use.
- Use cases
  Find details on common data analysis use cases and the add-ons that support them.
- Data analysis add-ons
  Data analysis add-ons provide ready-to-use analytical methods and capabilities for analyzing assays, combining results, organizing analytical workflows, and monitoring processes over time.
- Supporting add-ons
  Find details on add-ons that support and supplement data analysis add-ons.
Data import
Import of external response values and observation data into PLA 3.0 for further processing and evaluation.
User interface
The user interface of PLA 3.0 includes graphical and textual elements designed for daily workflows.
Installation and update
Deployment, installation, and update of PLA 3.0, including initial and advanced setup.
Licensing
The licensing solution of PLA 3.0, available licensing options, and the activation and management of licenses.
Administration
Setup and maintenance of databases and add-ons, user accounts, access rights, and migration and update procedures.
Regulatory compliance
PLA 3.0 supports users in achieving compliance with regulations such as ISPE GAMP^® 5 and 21 CFR Part 11.
Glossary
Definitions of central terminology used in PLA 3.0.

Suitability testing

Suitability testing ensures that assay results meet predefined performance criteria, confirming that the method is appropriate for its intended use.

The following table shows the types of test available for the respective document type:


Document type	Details	Available in add-on
bioMérieux endotoxin detection assay	Test system	bioMérieux Endotoxin Detection Assay Package
Cylinder plate assay (JP 4.02)	Test system	Microbial Assays for Antibiotics Package
Cylinder plate assay (USP <81>)	Test system	Microbial Assays for Antibiotics Package
Combination of assay results	Suitability testing	Biological Assay Package
Combination of microbial assays	Test system	Microbial Assays for Antibiotics Package
Dichotomous assay	Suitability testing	Dichotomous Assay Package
Dose-response analysis	Suitability tests	Dose-Response Analysis Package
Quantitative response assay	Suitability testing	Biological Assay Package
Turbidimetric assay (USP <81>/JP 4.02)	Test system	Microbial Assays for Antibiotics Package