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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 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.
Create simulations of quantitative response assays
Creating simulations of quantitative response assays is a three-step process.
Set up the simulation logic
Set up the logic according to which you want to simulate assays.
Configure the observations
You can change the settings read from your source documents if you require.

Get started
Explore PLA 3.0, its key features and ongoing enhancements, and learn how to log in and register.
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.
Key concepts
Details on documents and templates, the data editors and the Content editor of PLA 3.0. Learn about the position factors and data aggregation features.
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.
  - Installation
    Find details on the system requirements for the Biological Assay Simulation Package add-on and the steps to install the add-on in your environment.
  - Create simulations of quantitative response assays
    Creating simulations of quantitative response assays is a three-step process.
    - Set up the simulation logic
      Set up the logic according to which you want to simulate assays.
      - Create a QRA simulator document
        Create the QRA simulator document you want to use.
      - Read source documents
        If you want to use existing assays for simulation, you can read the required settings from these source documents, thus transferring them to the QRA simulation document.
      - Configure the observations
        You can change the settings read from your source documents if you require.
      - Configure the content
        Use the Content editor to configure the following global settings for the simulation.
    - Simulate the assay data
      After configuring the observations and the content of your QRA simulation document, you can create the simulated assays.
    - Generate the assay documents
      Create Quantitative response assay documents from your 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
Details on the deployment, installation, initial and advanced setup of PLA 3.0.
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.

Configure the observations

You can change the settings read from your source documents if you require.

To do so, you use the Observations editor. Usually, each row in this editor corresponds to the measurements of a single sample and dose combination. If multiple rows are created for the same sample and dose pair, the generated observations are merged. For each row, observations are generated by drawing from a normal distribution. You can configure the mean, variance, and sample size of the drawn sample.

The columns are:


Column	Description
Assay element	Contains the name of the assay element. Upon generation, all rows with the same assay element are be assigned to a single sample.
Dose	Each measurement must be associated with a dose. The dose is used for calculating the mean of the normal distribution. The dose is also used to assign measurements to a specific dose step in the generated Quantitative response assays. If multiple rows with the same dose are created for a single assay element, the generated observations are assigned to the same dose step. You can use this setting, for example, to force the resulting observations to contain an outlier at a specific dose.
Replicate	Number of observations created for this row.
Mean	Mean of the observations for this sample and dose pair. Can be used as a mean for the normal distribution generating the new observations.
Variance	Variance of the observations for this sample and dose pair, used as the variance for the normal distribution generating the new observations. If left empty, zero is used as a variance, that is, all replicates are equal to the used mean.
Parameters	All other columns contain parameters and their variance. The parameters, together with the dose, can be used to calculate the mean for the normal distribution used for generating new observations. If a parameter variance is given, new curve parameters are determined for each new assay using a normal distribution. All rows of an assay element use the same parameters. Note: Depending on the model, some parameter columns must remain empty. For example, for an assay using a 4-parameter logistic model, only the columns A, B, C, D, and their variances are needed. All other columns should remain empty.

Note: If you give both, parameters and a mean, for a specific observation row, the setting Simulation priority setting determines how PLA 3.0 generates the observations.