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.
You’re supposed to run your facility, not the other way around.
Concerned about maintaining your data integrity compliance status? Managing your equipment? Upcoming regulatory inspections? Take control of your equipment, data, and reporting.
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