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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.
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.
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.
Enter your observation data
Add your response values to the plate.

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.
  - 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.
    - Create an assay document
      Create a new bioMérieux endotoxin detection assay 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, Test, and Blank control samples.
    - Define the analytical settings
      Configure the regression model, and define the statistical tests you require to prove the validity of your assay.
    - Define your plate layout
      Define how your samples are arranged on your plate.
    - Enter your observation data
      Add your response values to the plate.
    - 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 bioMérieux endotoxin detection assay document type provided by the bioMérieux Endotoxin Detection Assay Package.
- 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 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.

Enter your observation data

Add your response values to the plate.

Note: In this use case, you manually add your data by copy and paste. If you use the bioMérieux Endotoxin Detection Assay Package in combination with the Tecan Magellan™ Import Module for bioMérieux Endotoxin Detection Assays, the import module provides the required data..

Before you begin

You have defined your plate layout.

Procedure

To enter your observation data:

In the By Position editor, select Initial response as the primary display factor.

Add the following response values:


	1	2	3	4	5	6	7	8	9	10	11	12
A	3822	3838	3833	3842	3829	3840	3828	3843	3840	3828	3843	3836
B	3822	3837	3840	3839	3853	3847	3843	3856	3847	3843	3856	3837
C	3838	3832	3825	3848	3825	3828	3831	3824	3828	3831	3824	3832
D	3836	3839	3841	3851	3827	3817	3823	3839	3817	3823	3839	3839
E	3832	3837	3845	3819	3850	3835	3832	3840	3816	3848	3853	3848
F	3854	3830	3845	3845	3853	3831	3857	3855	3852	3841	3837	3845
G	3866	3837	3842	3843	3853	3808	3832	3839	3839	3847	3832	3810
H	3845	3834	3848	3839	3845	3851	3824	3826	3843	3849	3854	3827

In the By Position editor, select Final response as the primary display factor.

Add the following final response values:


	1	2	3	4	5	6	7	8	9	10	11	12
A	3822	3838	10239	9401	9303	8892	8572	8675	9229	11670	8810	3836
B	53684	51284	9795	8951	9273	9510	10204	9274	9893	10252	10203	3837
C	8842	8623	4708	4883	4926	4847	4806	4780	5811	15696	5346	3832
D	4378	4456	4878	4859	4736	4724	4595	4631	5296	4821	4974	3839
E	3832	3837	3845	3819	3850	3835	3832	3840	3816	3848	3853	3848
F	3917	3907	3845	3845	3853	3831	3857	3855	3852	3841	3837	3845
G	3916	3910	3842	3843	3853	3808	3832	3839	3839	3847	3832	3810
H	3845	3834	3848	3839	3845	3851	3824	3826	3843	3849	3854	3827

Save the document.

What to do next

Calculate your assay document.