Data analysis add-ons offer a wide range of capabilities, ranging from analytical methods over comprehensive analysis to assay workflows and statistical process control.
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.
Find details on how you can use the Control Chart Package in your daily business.
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.
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.
Find details on the system requirements for the Control Chart Package add-on and the steps to install the add-on in your environment.
Use Control chart documents to set up your statistical process control mechanisms.
Create events for the dates on which you changed the cell culture and reference the events in rule sets to define the periods you want to monitor.
Color your observations depending on a secondary factor not shown in the plot. You can apply colors based on thresholds or utilizing an independent text column.
Monitor the EC50 of a dose-response analysis together with the interpolated Test sample concentrations. Monitor the effective and interpolated concentrations for individual days, and employ a sidechart that provides the mean EC50 and a three-sigma interval for the EC50.
Control chart documents allow for a comprehensive analysis of your assays and support you in setting up automated, semi-automated, and manual monitoring of your assays. They can aggregate data from different document types, such as Quantitative response assay documents or Dose-response analysis documents.
The reference provides reference information on the document types of the Control Chart 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.
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 add-ons that support and supplement data analysis add-ons.
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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