GxP Impedance Module
Achieve FDA 21 CFR Part 11 compliance in GMP/GLP labs with this Impedance Software version.
Overview
The GxP Impedance Module, paired with AxIS Z software, streamlines the setting up, execution, and analysis of impedance experiments in a GMP/GLP lab environment. It allows users to perform label-free and real-time assessments of cell proliferation, viability, morphology, immune cell-mediated killing, and viral cytopathic effects. This version is designed for ease of use, integrating auditing and compliance features to meet regulatory standards.
Key features of the GxP Impedance Module include full auditability and simplified assays that are easy to validate. Users can control experimental settings, access real-time cellular profiles, and conduct detailed analyses of cytolysis or barrier function with accuracy.
Assay Setup
- Built-in Maestro hardware test ensures precise impedance measurements in each experiment.
- Controlled user permissions regulate access to experiments and settings.
- Automatic acquisition and pre-configured analysis settings facilitate easy assay setup, with options for advanced settings as needed.
- Color-coded plate maps provide real-time information and track control types for automated analysis.
Real-time Data Tracking
- Continuous impedance data is available in real-time for each treatment group.
- Experiment and system-wide audit trails maintain records of changes, preserving original data.
- An integrated barcode scanner ensures data accuracy by associating data with the correct plates and auto-tracks events like plate docking.
- Automatic and user time-stamped notes mark critical events, aiding advanced analysis.
- Remote monitoring via the Maestro Z App allows tracking from outside the lab.
Data Analysis Tools
- Generate cytolysis curves and calculate 50% killing time values effortlessly.
- Investigate cellular barrier integrity using the Barrier Index feature in AxIS Z.
- Export figures and data tables for publication directly to Microsoft Excel® through the Lab Notebook, which supports live data and error bars.
- Protect data integrity with checksums while exporting files, ensuring unchanged experiment data.
This module is versatile, supporting various applications such as antiviral effect evaluation, cell barrier integrity monitoring, tumor biology modeling, as well as cell migration, invasion, viability studies, and more.
