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Analytical methods, comprehensive analysis, assay workflows, and statistical process control.
Biological Assay Package
Use the Biological Assay Package for potency analysis of biological assays. The add-on comes equipped with a highly flexible test system to qualify your assay. You can perform combination calculations to obtain the reportable value from independent assay runs and use historic assay data to develop equivalence margins.
Test system definition
Use Test system definition documents to define a collection of suitability tests and corresponding margins for quantitative response assays.

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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.
- Biological Assay Package
  Use the Biological Assay Package for potency analysis of biological assays. The add-on comes equipped with a highly flexible test system to qualify your assay. You can perform combination calculations to obtain the reportable value from independent assay runs and use historic assay data to develop equivalence margins.
  - Installation
    Find details on the system requirements for the Biological Assay Package add-on and the steps to install the add-on in your environment.
  - Basic bioassay protocol
    Use Basic bioassay protocol documents to set up a workflow for producing reportable values from multiple independent assay runs. Organize complex methods, retest scenarios, and report several products in a single assay.
  - Combination of assay results
    Use Combination of assay results documents to perform combination calculations for independent assay runs, thus obtaining reportable values for the potency.
  - Equivalence margin development
    Use Equivalence margin development documents to develop and verify test systems based on historic assays and apply these test systems in new development of quantitative response assays.
  - Quantitative response assays
    Use Quantitative response assay documents to calculate the potencies of test samples relative to an established standard. You can also use them to determine absolute potencies based on stock solutions or raw materials.
  - Test system definition
    Use Test system definition documents to define a collection of suitability tests and corresponding margins for quantitative response assays.
    - Assay and sample suitability tests
      Find details on the assay and sample suitability tests available for the Quantitative response assay document type.
    - Document suitability tests
      Find details on the document suitability tests available for the Quantitative response assay document type.
  - Use case: Automate a bioassay workflow
    For some biological assays, determining relative potency within a single run is not sufficient. In these cases, you perform multiple individual assay runs and then combine the resulting data to obtain a more reliable final potency estimate. The challenge is to combine these individual results efficiently and reproducibly, particularly in regulated environments or when preparing for automated workflows.
  - Reference information
    Find reference information on the document types of the Biological Assay Package add-on.
- bioMérieux Endotoxin Detection Assay Package
  Use the bioMérieux Endotoxin Detection Assay Package add-on to perform endotoxin testing based on recombinant factor C (rFC), a synthetic alternative to naturally sourced reagents derived from horseshoe crabs, as offered by the bioMérieux company.
- Control Chart Package
  The Control Chart Package allows sophisticated statistical process control (for example, by plotting Shewhart I-Charts as recommended in the USP <1010>). It provides visualization options for intervals, subcharts and sidecharts, and allows you to define colors by a secondary characteristic. You can also define rules based on events and time frames.
- Dichotomous Assay Package
  Use the Dichotomous Assay Package to analyze biological assays based on quantal (binary) responses by fitting probit or logit models to estimate the potency of your samples.
- Dose-Response Analysis Package
  The Dose-Response Analysis Package provides various biostatistical methods for immunoassays, ELISA, and more. It supports you in investigating equivalence for calibration curves, provides enhanced data processing, and options for subgroup analysis.
- Microbial Assays for Antibiotics Package
  The Microbial Assays for Antibiotics Package for PLA 3.0 is your software for assessing the potency of antibiotics. This add-on supports various methods, that is, cylinder-plate, turbidimetric, and combination of microbial assays. It enables you to closely follow the guidelines laid out in the United States Pharmacopeia (USP <81>) and the Japanese Pharmacopoeia (JP 4.02).
- 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.

Test system definition

Use Test system definition documents to define a collection of suitability tests and corresponding margins for quantitative response assays.

Tip:

Before you start working with this document type, we recommend becoming familiar with the documents concepts in PLA 3.0. For details, see the Documents topic.

About this document type

Test system definition documents let you set up a centralized suitability test system for repeated use. Instead of defining tests within each Quantitative response assay document, you reference a shared Test system definition document to ensure consistency across your assays.

Tip:

You can identify documents of this type by the

icon in the upper right corner of the Content editor.

You can include one or more suitability tests in each Test system definition document and define their parameters, scope, and severity level. For details on these settings, see the Suitability testing topic.

In the following example, a Test system definition document is referenced by three Quantitative response assay documents:

Flowchart with three blue boxes labeled 'Quantitative response assay 1,' 'Quantitative response assay 2,' and 'Quantitative response assay 3,' each pointing upward to a dark teal box labeled 'Test system definition.' — Figure 1. Test system definition document referenced by three Quantitative response assay documents

To set up these references, you use the Content editor of your Quantitative response assay document. For details on the required steps, see the Create references to documents topic.

Document structure

Each Test system definition document have one default section, that is Suitability tests, plus one or more optional Comment sections. Use the subsections to add the assay, sample, and document suitability tests you require.

Figure 2. Sections of a Test system definition document displayed in the Content editor

Suitability tests

Test system definition documents for quantitative response assay offer suitability tests of the following types. For details on each test, see the respective subtopic.


Type	Description
Assay suitability tests	The results of assay suitability tests affect the whole assay document rather than just individual Standard-vs-Test sample comparisons.
Sample suitability tests	The results of sample suitability tests just affect the individual Standard-vs-Test sample comparison for which they are set rather than the whole assay document.
Document suitability tests	The results of document suitability tests affect the whole assay document.