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.
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.
Creating simulations of quantitative response assays is a three-step process.
Set up the logic according to which you want to simulate assays.
Explore PLA 3.0, its key features and ongoing enhancements, and learn how to log in and register.
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.
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.
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.
Find details on the system requirements for the Biological Assay Simulation Package add-on and the steps to install the add-on in your environment.
Create the QRA simulator document you want to use.
If you want to use existing assays for simulation, you can read the required settings from these source documents, thus transferring them to the QRA simulation document.
You can change the settings read from your source documents if you require.
Use the Content editor to configure the following global settings for the simulation.
After configuring the observations and the content of your QRA simulation document, you can create the simulated assays.
Create Quantitative response assay documents from your simulated data.
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.
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.
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.
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.
Use the Generic Document Types Package add-on to document general information.
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.
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.
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).
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.
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.
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.
Details on the deployment, installation, initial and advanced setup of PLA 3.0.
Details on the licensing solution of PLA 3.0, the available licensing options, and the activation and management of licenses.
Details on system administration tasks such as setup and maintenance of databases and add-ons, user accounts, access rights, and migration and update procedures.
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.
Download PDF guides of current and previous framework and add-on versions.
Meet the team at Stegmann Labs, where PLA 3.0 plays an essential role in every step of bioassay management.
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