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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.
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.
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.
Define a test system
New assay documents of the Microbial Assays for Antibiotics Package do not contain any statistical tests. Add the assay suitability and sample suitability tests you require.

Get started
Explore PLA 3.0, its key features and ongoing enhancements. Learn how it fits into your environment, and 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.
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.
- 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).
  - 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 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.
      - Change concentration sequence
        New Turbidimetric assay (USP <81>/JP 4.02) documents have 5 concentrations of the standard, that is, 1 reference concentration, which is the median level, plus 4 extra concentrations. You can change concentration values, add or delete concentrations, and change the position of concentrations in the sequence.
      - Add controls and define rack layouts
        New Turbidimetric assay (USP <81>/JP 4.02) documents have a standard with a 5-step concentration sequence and a single test sample. You can add controls and extra test samples. To assist you in keeping track of the spatial arrangement of your samples, you can also create a visual representation of your rack layouts.
      - Add response data processing
        New assay documents of the Microbial Assays for Antibiotics Package contain response data processing steps. However, none of the steps is active. To define how PLA 3.0 should process your response data before calculating potencies, you need to activate the respective steps in your assay document.
      - Define a test system
        New assay documents of the Microbial Assays for Antibiotics Package do not contain any statistical tests. Add the assay suitability and sample suitability tests you require.
      - Define combination groups
        Assign samples to combination groups to control which samples PLA 3.0 includes in combination of assays calculations. All valid samples of a combination group are combined in the calculations performed by Combination of microbial assays documents that reference these samples or, to be more precise, that reference the assay documents which contain these samples.
  - 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.
- 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
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 of Stegmann Labs Inc. and use our sample laboratory to explore core features and functions of PLA 3.0.
Glossary
Find definitions of terms.

Define a test system

New assay documents of the Microbial Assays for Antibiotics Package do not contain any statistical tests. Add the assay suitability and sample suitability tests you require.

In this example, we use a Turbidimetric assay (USP <81>/JP 4.02) document to show how you define a test system.

Before you begin

Create a Turbidimetric assay (USP <81>/JP 4.02) document.

About this task

To comply with USP <81>, you can set up the following assay suitability and sample suitability tests:

Combined standard deviation of the standard
Coefficient of determination (R²)
Relative potency (percentage of reference concentration)

Procedure

To set up your assay suitability tests:

In the Content editor, go to Analysis > Test system > Assay suitability tests.
Use the Creatable elements pane to add a Test: Combined standard deviation of the standard and a Test: Coefficient of determination(R2) element.
Result: PLA 3.0 adds both tests to the Assay suitability tests section.
Go to Test: Combined standard deviation of the standard and set up the test as follows:
1. Set the limit for the combined standard deviation of the standard as the Upper margin. Enter .1.
2. Leave the rest of the settings unchanged.
Go to Test: Coefficient of determination(R2) and set up the test as follows:.
1. Set the limit for the coefficient of determination as the Lower margin. Enter .9.
2. Leave the rest of the settings unchanged.

To set up your sample suitability tests:

Go to Sample suitability tests.
Use the Creatable elements pane to add a Test: Relative potency (percentage of reference concentration) element.
Result: PLA 3.0 adds the test to the Sample suitability tests section.
Go to Test: Relative potency (percentage of reference concentration) and set up the test as follows:
1. Set the upper limit for the relative potency of test samples compared to the reference concentration of the standard as the Upper margin. Enter 125.
2. Set the lower limit for the relative potency of test samples compared to the reference concentration of the standard as the Lower margin. Enter 80.
3. Makes sure that the Assay element type scope is set to Test samples only (default).
Save the document.

Result

Your test system should now look like this:

Figure 1. Test system section of a Turbidimetric assay (USP <81>/JP 4.02) document displayed in the Content editor