The need to investigate out-of-specification results continues to be one of the most commonly observed cGMP issues during QC lab 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.
As an all-encompassing endotoxin data management platform, Charles River Cortex™ empowers you to make informed, confident decisions while maintaining a centralized state of control throughout your manufacturing facility. As a client-server based data management platform, Cortex provides an integrated solution to securely consolidate, query, and analyze all real-time endotoxin data for necessary internal QA and FDA trending reports.
Concerned about maintaining your data integrity compliance status? Managing your equipment? Upcoming regulatory inspections? Take control of your equipment, data, and reporting.
IMPACT OF 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 elevate effortlessly your compliance status.
TRANSFORM DATA INTO RESULTS
- Real-time data tracking and trending
- Operational management of equipment fleet
- Rules-based email alerts
- Searchable audit log
- Customizable graphs and reports
- EndoScan-V™ version 5.5.4 and higher integration
- Available in six languages
- Electronic signatures for all Endosafe® cartridge readers
- Enhanced user management profiles