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Data analysis
Data analysis add-ons offer a wide range of capabilities, ranging from analytical methods over comprehensive analysis to statistical process control. PLA 3.0 also provides a set of add-ons that support and supplement data analysis add-ons.
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 a reportable value from independent assay runs and use historic assay data to develop equivalence margins.
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.

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Details on documents and templates, the data editors and the Content editor of PLA 3.0.
Data analysis
Data analysis add-ons offer a wide range of capabilities, ranging from analytical methods over comprehensive analysis to statistical process control. PLA 3.0 also provides a set of add-ons that support and supplement data analysis add-ons.
- 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 a 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 combine the results of multiple independent assay runs into reportable values. 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.
    - Combination calculation methods
      The combination calculation method determines the weighting of the results from the independent assay runs during the calculation process.
    - Basic concepts
      Combination of assay results documents use a set of concepts you should be familiar with when working with this document type.
    - Compendial guidance
      The methods and procedures provided by the Combination of assay results document type are based on use cases and requirements from literature.
  - Equivalence margin development
    Use Equivalence margin development documents to utilize data of historic assays to develop and verify test systems and use these systems to apply them in new assay development.
  - Quantitative response assays
    Use Quantitative response assay documents to calculate relative potencies of Test samples compared to a Standard sample. If you provide information on the stock solutions or raw materials, you can also determine absolute potencies based on several types of calculations.
  - Test system definition
    Use Test system definition documents to define a collection of suitability tests and corresponding margins for Quantitative response assays.
  - Reference information
    Find reference information on the document types of the Biological Assay Package add-on.
- Biological Assays Simulation Package
  Use the Biological Assays Simulation Package to create simulations of quantitative response assays (QRAs) and use the Quantitative response assay document type of PLA 3.0 to store the simulated data.
- 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.
- Generic Document Types Package
  Use the Generic Document Types Package add-on to document general information.
- Integration Report Package
  Use the Integration Report Package for creating reports in additional file formats that are not covered by the standard PLA 3.0 reporting functionality. These reports can be used for example for automated processing in third-party software.
- Measurement Documentation Package
  The Measurement Documentation Package add-on is a universal add-on for documenting different aspects of a measurement. Its documents can be referenced by other document types, for example, Quantitative response assays.
- 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).
- Split Assay Package
  Use the Split Assay Package to split a Quantitative response assay with several Test and Control samples into individual assays, each with the Standard and one Test or Control sample.
- Toolkit for Biological Assay Package
  Use the Toolkit for Biological Assay Package to modify the analytical settings of larger sets of Quantitative response assays or split Quantitative response assays with more than one test or control sample into individual assays.
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.
Installation
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Licensing
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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.
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Glossary
Find definitions of terms.

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.

About this document type

Combination calculations let you to improve the precision of the result, and to account for variations such as variability in cells or different operators. You can set up combination calculations for Quantitative response assay documents and Dichotomous assay documents.

Tip: You can identify assays of this document type by the

icon in the upper right corner of the Content editor.

Document structure

Each Combination of assay results document has three default sections, that is, Documentation, Setup, and Analysis, plus one or more optional Comment sections.

Figure 1. Sections of a Combination of assay results document displayed in the Content editor


Section	Description
Documentation	Add groups. A group usually corresponds to a reportable value. You can use groups to add information with which to identify the substance to the report.
Setup	Adjust the dataset structure used to summarize reportable values generated by the Combination of assay results document.
Analysis	Specify the combination type, compendial guidance, potency type, logarithm type, and the suitability tests to be used in calculations.
Comment	Add extra information to your assay. The PDF reports display the comments you add on the first page.