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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.
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.
Use case: Determine total human thyroxine (T4)
Thyroxine (T4) is a commonly measured thyroid hormone for diagnosis of the thyroid function. Determining the total quantity of human thyroxine in serum is a standard use case for interpolation on a calibration curve.

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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.
Key concepts
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.
- 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.
  - Installation
    Find details on the system requirements for the Dose-Response Analysis Package add-on and the steps to install the add-on in your environment.
  - Dose-response analysis
    Use Dose-response analysis documents to perform curve comparisons and create calibration curves.
  - Equivalence margin development
    Use Equivalence margin development documents to utilize data of earlier assays to develop and verify test systems and export these systems to apply them in new assay development.
  - Test system definition
    Use the Test system definition document type to define a collection of suitability tests and corresponding margins for Dose-response analysis documents.
  - Use case: Determine total human thyroxine (T4)
    Thyroxine (T4) is a commonly measured thyroid hormone for diagnosis of the thyroid function. Determining the total quantity of human thyroxine in serum is a standard use case for interpolation on a calibration curve.
    - Create an assay document
      Create a new Dose-response analysis document to hold your assay data.
    - Set up the assay elements
      Set up the assay elements required for this use case, that is, elements for the Standard and the Test samples.
    - Set up the preparation schemes
      Set up preparation schemes to define the doses and dimensions of your treatments.
    - Define your plate layout
      Define how your samples are arranged on your plate.
    - Enter your observation data
      Add your response values to the plate.
    - Define the analytical settings
      Configure the response data processing logic, the analytical model, and select the suitability test you want to apply.
    - Calculate your assay document
      After you entered the response values and finished the setup of your document, you can calculate the reportable values.
  - Reference information
    Find reference information on the document types of the Dose-Response Analysis Package add-on.
- 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
Details on the deployment and installation of licensed PLA 3.0 versions.
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.
PDF downloads
Download PDF guides of current and previous framework and add-on versions.
Sample lab
Meet the team of Stegmann Labs Inc. and use our sample laboratory to explore core features and functions of PLA 3.0.
Glossary
Find definitions of terms.

Use case: Determine total human thyroxine (T4)

Thyroxine (T4) is a commonly measured thyroid hormone for diagnosis of the thyroid function. Determining the total quantity of human thyroxine in serum is a standard use case for interpolation on a calibration curve.

Plate layout

For this use case, you work with an assay document with a 96-well plate layout. The assay has one Standard sample and six Test samples.

The following figure shows the distribution of samples on the plate:

Figure 1. Distribution of samples on a 96-well plate for the determination of total human thyroxine

Steps

Setting up assay for the determination of total human thyroxine comprises the following steps:

Figure 2. Steps for setting up an assay for the determination of total human thyroxine

You start by creating a new Dose-response analysis document. In the next steps, you use the Content editor to set up the assay elements for your samples and the preparation schemes, followed by the definition of the analytical settings. In steps five and six, you use the By Position editor to define your plate layout and enter your observation data. As the last step, you calculate the reportable values for your assay.

Results

Once calculated, you can access the document dashboard to view key document attributes, a graphical summary of the calculation results, and a representation of the plate layout you used for the assay.

To open the dashboard of a document, on the action bar, select Dashboard. For details on how to work with the dashboard, see the Dashboard topic.

Figure 3. Dashboard of a Dose-response analysis document

Reporting

Create reports to download and share your assay results. PDF reports contain the data available on the dashboard, enriched with details like the database that holds the document, and detailed calculation results for each assay element. Use CSV reports to export your assay data for further processing.

To generate a report for a document, on the action bar, select Report. For details on how to work with reports, see the Create reports topic.