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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.
Supporting add-ons
Find details on add-ons that support and supplement data analysis add-ons.

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 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.
- 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.
  - 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.
  - Generic Document Types Package
    Use the Generic Document Types Package add-on to organize contact-related data, create and manage reminders or internal comments, or streamline workflows where data needs to be consistently organized and referenced.
  - 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.
  - 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.

Supporting add-ons

Find details on add-ons that support and supplement data analysis add-ons.

The following figure highlights the tooling capabilities that support your data analysis process in PLA 3.0:

Figure 1. Capabilities of supporting add-ons in PLA 3.0

All add-ons come equipped with a set of document types, each of which covers a specific capability. To make use of a capability, activate the respective add-on in your PLA 3.0 database and create a document of the respective type. For details on how to activate add-ons, see the Activate add-ons topic.

Test system

Set up a sophisticated test system. All data analysis add-ons offer capabilities that let you set up a custom set of suitability tests. The following add-ons let you set up specific Test system definition documents that you can link to your assay documents for repeated use:

Resources

Maintain details on instruments, operators, reagents, and more. The following supporting add-ons offer resource-related capabilities:


Add-on	Capability
Generic Document Types Package	Provides a set of document types that you can use to document general information, that is contact information, notes, and tables.
Measurement Documentation Package	Provides a set of document types that you can use to document different aspects of a measurement, that is, operator, equipment, and substance.

Tools

Perform bulk adjustments, advanced reporting, and create simulations of quantitative response assays. The following supporting add-ons offer tooling:


Add-on	Capability
Biological Assays Simulation Package	Provides the QRA simulator and QRA collector document types that you can use to create simulations of quantitative response assays.
Integration Report Package	Lets you create reports in extra file formats that are not covered by the standard PLA 3.0 reporting functionality.
Split Assay Package	Lets you split quantitative response assays into one-on-one assays.
Toolkit for Biological Assay Package	Lets you perform bulk adjustments, that is, modify the analytical settings of larger sets of quantitative response assays. It also lets you split quantitative response assays into one-on-one assays.