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Creating centralized control for a decentralized approach.

Maintaining the long-term safety of a manufacturing environment while meeting the demands of compliance is a microbial quality control manager’s top priority. The need to investigate out-of-specification (OOS) results continues to be one of the most commonly observed cGMP issues during quality control laboratory inspections, so having access to accurate, relevant and reliable data is essential to support confident decisions on product quality. Moreover, FDA warning letters and new global guidance documents communicate the increasing requirements on data integrity, making many organizations aware of existing gaps and deficiencies in their data and reporting.

Driving Efficiencies Through Risk Mitigation

Impact of Charles River Cortex™

Make informed, confident decisions through an integrated, all-encompassing endotoxin test management infrastructure.

Maintain a complete state of control through real-time tracking and trending.

Continuously monitor endotoxin results and create custom alerts to address issues and simplify lab investigations.

Meets current global data integrity guidance standards.

Gain complete QA/QC oversight, increase visibility into key performance indicators and proactively manage the operational integrity of your equipment fleet.

Securely consolidate and analyze all endotoxin data in real-time for necessary internal QA and FDA trending reports to effortlessly elevate your compliance status.

Transform Analytical Data into Actionable Results
Testing Platform Flexibility

Compile data from any Endosafe® rapid testing platform or microplate and tube reader to make informed, confident decisions in your manufacturing operation.

Endosafe® nexgen-PTS™

Portable Testing

This rapid, point-of-use handheld spectrophotometer utilizes USP/BET-compliant disposable cartridges for accurate, convenient, and real-time endotoxin testing, glucan concentration determination, and Gram identification. The advanced features address your needs for decreased assay run time, simplified data entry, reduced user variability, and enhanced QA control. User Management supports readiness for 21 CFR Part 11 compliance.

Endosafe® nexgen-MCS™

Multiple Sample Testing

This bench-top system tests up to five samples simultaneously within 15 minutes. Each sample runs independently, allowing for random access and traceability, so you can run your samples as needed and not wait for a full batch of samples. Endotoxin measurement and assay acceptance criteria are calculated by EndoScan-V™, our 21 CFR Part 11-compliant ready software.

Endosafe® Nexus™

Automated High-Throughput Testing

With the increasing demand for a high-throughput automated system, we incorporated our multi-cartridge technology into a simple, walk-away robotic solution. Utilizing a state-of-the-art automated dilution and sample handling system, users have the ability to suspend current run and test up to 60 samples with minimal preparation and supervision.

Kinetic Testing Systems

The Cortex software platform interfaces with a variety of microplate plate readers, allowing users to monitor, record, approve and track equipment and system performance, and bring together all relevant operational data from within the same framework. For systems that require EndoScan-V™ software as the data driver, Cortex can easily be configured to automatically import the exported data from version 5.5.4 and higher.

Additional Features for Supported Platforms

Automatically transfer data to a LIMS system via digitally signed XML.

Export filtered data to an Excel CSV or digitally signed XML file.

Sort and filter data in a customizable grid.

Digitally sign and attach comments to test records for all Endosafe® cartridge readers.

Sort data using customizable rules and ranges.

View audit trails of user actions and export to PDF.

Configure users, roles, report styles, and other settings.

Backup/restore the database within the server-side user interface.

Automatically schedule database backups (minimum daily).

Take Control of Your Data

Contact us today to transform the way you manage your endotoxin data and safeguard your facility with Charles River Cortex™.

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