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.
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. Learn how it fits into your environment, and 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.
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 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.
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.
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 and installation of licensed PLA 3.0 versions.
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.
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