Analytical methods, comprehensive analysis, 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.
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.
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.
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.
