Analytical methods, comprehensive analysis, assay workflows, and statistical process control.
Find details on 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.
Overview of the PLA 3.0 software, its ongoing improvements and version updates, and the available trial options.
Structural foundation for daily work and support for method development from initial design to routine production.
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 the reportable value from independent assay runs and use historic assay data to develop equivalence margins.
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.
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).
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 Generic Document Types 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.
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 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.
Use the PLA 3.0 Migration and Archiving Toolkit if you are running a PLA 2.0 or PLA 2.1 installation and want to migrate your databases to a PLA 3.0 environment.
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.
Import of external response values and observation data into PLA 3.0 for further processing and evaluation.
The user interface of PLA 3.0 includes graphical and textual elements designed for daily workflows.
Deployment, installation, and update of PLA 3.0, including initial and advanced setup.
The licensing solution of PLA 3.0, available licensing options, and the activation and management of licenses.
Setup and maintenance of databases and add-ons, user accounts, access rights, and migration and update procedures.
PLA 3.0 supports users in achieving compliance with regulations such as ISPE GAMP® 5 and 21 CFR Part 11.
Stegmann Labs serves as the sample lab for scenarios illustrating the use of PLA 3.0 across bioassay analysis workflows.
Definitions of central terminology used in PLA 3.0.
