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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.
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).
Turbidimetric assays (USP <81>/JP 4.02)
Use Turbidimetric assay (USP <81>/JP 4.02) documents to determine the potency of antibiotics according to the turbidimetric methods described in USP <81> and JP 4.02. PLA 3.0 uses a linear regression model to fit the standard curve.
Assay setup
To support you in setting up your assay, Turbidimetric assay (USP <81>/JP 4.02) documents provide a set of concepts you should be familiar with when working with this document type.
Assay design
Turbidimetric assay (USP <81>/JP 4.02) documents do not have an Assay design section. You set the concentrations and number of replicates in the assay elements.

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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.
- 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).
  - Installation
    Find details on the system requirements for the Microbial Assays for Antibiotics Package add-on and the steps to install the add-on in your environment.
  - Cylinder plate assays (USP <81>)
    Use Cylinder plate assay (USP <81>) documents to determine the potency of antibiotics according to the cylinder-plate method described in USP <81>. PLA 3.0 uses a linear regression model to fit the standard curve. This method allows you to correct for plate-to-plate variation.
  - Cylinder plate assays (JP 4.02)
    Use Cylinder plate assay (JP 4.02) documents to determine the potency of antibiotics according to the cylinder-plate method described in JP 4.02. PLA 3.0 compares the response values of the test sample at high and low concentration to the response of the standard at high and low concentration.
  - Turbidimetric assays (USP <81>/JP 4.02)
    Use Turbidimetric assay (USP <81>/JP 4.02) documents to determine the potency of antibiotics according to the turbidimetric methods described in USP <81> and JP 4.02. PLA 3.0 uses a linear regression model to fit the standard curve.
    - Assay setup
      To support you in setting up your assay, Turbidimetric assay (USP <81>/JP 4.02) documents provide a set of concepts you should be familiar with when working with this document type.
      - Assay design
        Turbidimetric assay (USP <81>/JP 4.02) documents do not have an Assay design section. You set the concentrations and number of replicates in the assay elements.
      - Concentrations of the standard
        Specify concentrations of the reference standard in a Turbidimetric assay (USP <81>/JP 4.02) document by setting up a stepwise concentration sequence.
      - Assay elements
        In PLA 3.0, assay elements are the building blocks of assay documents. By default, Turbidimetric assay (USP <81>/JP 4.02) documents contain one assay element for the reference standard and one assay element for the test sample.
    - Assay analysis
      Define the analytical settings of your Turbidimetric assay (USP <81>/JP 4.02) document.
    - Calculation
      Turbidimetric assay (USP <81>/JP 4.02) document calculations closely follow the guidelines laid out in USP <81> and/or JP 4.02.
    - Test system
      The test system of assay documents lets you set up sophisticated tests to validate the suitability of your assays and plausibility of results. The Microbial Assays for Antibiotics Package provides a range of tests for each document type.
    - Set up Turbidimetric assays (USP <81>/JP 4.02)
      Find examples on how to set up and work with the Turbidimetric assay (USP <81>/JP 4.02) document type of the Microbial Assays for Antibiotics Package.
  - Combination of microbial assays
    Use Combination of microbial assays documents to aggregate data of samples contained in any number of microbial assay documents, apply confidence limits, check for outliers, perform combination of assays calculations, and define statistical tests.
  - Literature
    The methods and procedures provided by the Microbial Assays for Antibiotics Package are based on use cases and requirements from literature.
  - Reference information
    Find reference information on the document types of the Microbial Assays for Antibiotics Package add-on.
- 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.

Assay design

Turbidimetric assay (USP <81>/JP 4.02) documents do not have an Assay design section. You set the concentrations and number of replicates in the assay elements.


Setting	Standard	Test	Control
Stepwise concentration sequence	X
Predilution		X	X
Number of replicates	X	X	X

The following default settings are available:


Assay element	Setting	Value
Standard	Number of replicates	3
Standard	Stepwise concentration sequence	Concentration: 1.5625 Concentration: 1.25 Reference concentration: 1 Concentration: 0.8 Concentration: 0.64
Test	Number of replicates	4