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Data analysis
Data analysis add-ons offer a wide range of capabilities, ranging from analytical methods over comprehensive analysis to 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.
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.
Set up the combination template
Combining assay results is a common task in regulated environments, especially when you need to report results from repeated assay runs. PLA 3.0 supports combination calculations by providing combination templates. You use these templates to prepare the logic according to which PLA 3.0 combines results.

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Key concepts
Learn how the key concepts of PLA 3.0 form the structural foundation for your daily work, supporting method development from initial design to routine production.
Data analysis
Data analysis add-ons offer a wide range of capabilities, ranging from analytical methods over comprehensive analysis to 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 of the Biological Assay Package to define a collection of suitability tests and corresponding margins for Quantitative response assay documents.
  - 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.
    - Set up the assay template
      Performing daily assay runs is a common scenario in Good Manufacturing Practice (GMP) environments. PLA 3.0 supports routine assay analysis by providing assay templates. You use these templates to prepare a standard setup for the assays that PLA 3.0 generates.
    - Set up the combination template
      Combining assay results is a common task in regulated environments, especially when you need to report results from repeated assay runs. PLA 3.0 supports combination calculations by providing combination templates. You use these templates to prepare the logic according to which PLA 3.0 combines results.
      - Create the combination calculation template
        Combination calculation templates hold settings required to perform combination calculations. Create the combination calculation template required for this use case.
      - Select how to combine assay results
        PLA 3.0 provides a variety of combination calculation methods for combining assay results. Select the method, compendial guidance, and the potency type required for this use case.
    - Set up the protocol template
      Protocol templates act as reusable workflow definitions. They let you organize recurring analysis tasks, such as evaluating multiple assay runs, applying predefined combination logic, and generating consistent protocol documents. By setting up the protocol template, you create the structure that PLA 3.0 follows when it processes assay data.
    - Perform routine analysis
      Use the protocol template to run the routine analysis for your bioassay workflow. Routine analysis applies the workflow logic you defined earlier and processes the assay data as it becomes available. This step shifts from preparing templates to executing the actual analysis and evaluating the assay results.
  - 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
Use data acquisition and data import add-ons to import external response values and observation data into PLA 3.0 for further processing and evaluation.
User interface
PLA 3.0 supports you in your daily work by providing a set of graphical and textual user interface elements. Learn about the different elements and how to use them efficiently.
Installation and update
Details on deployment, installation, and update of PLA 3.0, and its initial and advanced setup.
Licensing
Details on the licensing solution of PLA 3.0, the available licensing options, and the activation and management of licenses.
Administration
Details on system administration tasks such as setup and maintenance of databases and add-ons, user accounts, access rights, and migration and update procedures.
Regulatory compliance
PLA 3.0 supports you in achieving compliance with regulations such as ISPE GAMP^® 5 and 21 CFR Part 11. It also provides options to validate PLA 3.0 in your environment.
PDF downloads
Download PDF guides of current and previous framework and add-on versions.
Sample lab
Meet the team at Stegmann Labs, where PLA 3.0 plays an essential role in every step of bioassay management.
Glossary
Find definitions of terms.

Set up the combination template

Combining assay results is a common task in regulated environments, especially when you need to report results from repeated assay runs. PLA 3.0 supports combination calculations by providing combination templates. You use these templates to prepare the logic according to which PLA 3.0 combines results.

This is the second step in setting up an automated bioassay workflow.

Before you begin

This task uses the Combination of assay results document type of PLA 3.0. We recommend becoming familiar with this document type before setting up the assay template. For details, see the Combination of assay results topic.

About this task

Combination templates define the settings that PLA 3.0 requires to aggregate the run results to calculate reportable values. In this task, you set up PLA 3.0 to calculate the relative and the absolute potency, with the confidence interval accounting for variation within each assay run.

Procedure

To set up the combination template:

Begin by creating the combination calculation template. Then, select the parameters that determine how PLA 3.0 should combine assay results.

Note: The assays you work in this use case have one test sample only. You therefore do not use combination groups.