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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.
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.
Reference information
Find reference information on the bioMérieux endotoxin detection assay document type provided by the bioMérieux Endotoxin Detection Assay Package.
CSV report
Use the CSV report reference to access information on the content of the bioMérieux endotoxin detection assay CSV report created by the bioMérieux Endotoxin Detection Assay Package.
Standard sample elements
The Standard sample elements of CSV reports provide information about the reference standard, the fitted model and the individual dose steps of the Standard sample. For each step there are 'STD' rows with steps in square brackets.

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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 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 a 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.
  - Installation
    Find details on the system requirements for the bioMérieux Endotoxin Detection Assay Package add-on and the steps to install the add-on in your environment.
  - bioMérieux endotoxin detection assays
    Use bioMérieux endotoxin detection assay documents to detect or extrapolate endotoxin concentrations in potentially contaminated test substances by comparison with a defined endotoxin dilution series.
  - Templates
    The bioMérieux Endotoxin Detection Assay Package comes equipped with endotoxin detection assay templates, preconfigured with the analytical settings, test system, and assay layout required for the respective assay kit.
  - Use case: Validate a cleaning process for pharmaceutical water
    In the pharmaceutical industry, water is an important resource both in synthesizing and developing products and in cleaning vessels and other types of equipment. Validating the cleaning processes for pharmaceutical water to prevent product contamination is therefore crucial.
  - Reference information
    Find reference information on the bioMérieux endotoxin detection assay document type provided by the bioMérieux Endotoxin Detection Assay Package.
    - bioMérieux endotoxin detection assay documents
      Find details on the document structure of bioMérieux endotoxin detection assay documents and access reference information on particular document elements.
    - Digest of document properties for data aggregation
      Find a list of property keys available for data aggregation in the bioMérieux Endotoxin Detection Assay Package add-on.
    - CSV report
      Use the CSV report reference to access information on the content of the bioMérieux endotoxin detection assay CSV report created by the bioMérieux Endotoxin Detection Assay Package.
      - CSV report outline
        PLA 3.0 generates CSV reports for bioMérieux Endotoxin Detection Assay Package documents as text files containing comma-separated values. The text files contain the test results, structured based on the assay elements.
      - Assay properties elements
        CSV reports start with the assay properties elements.
      - Standard sample elements
        The Standard sample elements of CSV reports provide information about the reference standard, the fitted model and the individual dose steps of the Standard sample. For each step there are 'STD' rows with steps in square brackets.
      - Test sample elements
        The Test sample elements of CSV reports provide result data of the Test samples together with one PPC per sample.
      - Blank control elements
        The lank control elements provide result data of the Blank controls.
      - PPC control elements
        The PPC control elements provide result data of the PPC control.
- 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).
- 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.
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.

Standard sample elements

The Standard sample elements of CSV reports provide information about the reference standard, the fitted model and the individual dose steps of the Standard sample. For each step there are 'STD' rows with steps in square brackets.

Example

See the following abstract from an example report with the standard elements:

Report example

For a detailed description of this type of assay element, see the Assay elements topic.

Available elements


Key	Description	Entry in Validity column	Usage
Name	Name of the Standard sample	no	mandatory
A lower asymptote	Lower asymptote of the fitted 4PL model	'valid' or 'invalid' (if the test is set up)	optional (depending on the test either A, B, C, D, or Intercept/Slope)
B parameter	B parameter (slope factor) of the fitted 4PL model	'valid' or 'invalid' (if the test is set up)
C parameter	C parameter (log EC50) of the fitted 4PL model	'valid' or 'invalid' (if the test is set up)
D upper asymptote	Upper asymptote of the fitted 4PL model	'valid' or 'invalid' (if the test is set up)
Intercept	Intercept of the fitted linear model	'valid' or 'invalid' (if the test is set up)
Slope	Slope of the fitted linear model	'valid' or 'invalid' (if the test is set up)
\|r\|	Coefficient of determination	'valid' or 'invalid' (if the test is set up)	mandatory
Activity	Activity per step	no	mandatory
CV(%)	CV (coefficient of determination) in percent, per step	'valid' or 'invalid' (if the test is set up)	mandatory

Special values for the Activity element

For the Activity element in the report, in certain cases it is not possible to calculate a real numerical value.

The following table shows these values and the possible reasons:


Value	Possible reasons	Remarks
-	No valid responses	Standard steps without valid responses are not shown in the CSV report. They do not have an activity.
NaN (Not a Number)	Every valid response matches one of the following criteria:
	Response is a technical outlier
	Interpolation formula leads to an unquantifiable value for the response	Fallback if NaN values are generated during the calculation (for example: Response > upper asymptote)
	Interpolated dose to response is negative	Can only occur with the 4-parameter logistic model, as the linear model is delogarithmized to calculate the interpolated dose.