Charles River's Endosafe® Endotoxin testing software is designed specifically to help reduce variability and increase operational efficiencies by achieving quantitative results and incorporating flexible configuration capabilities. Meeting or exceeding industry data integrity compliance guidelines according to 21 CFR Part 11, Endosafe® EndoScan-V™ and Charles River Cortex™ provide your full endotoxin testing software solution.

Endosafe EndoScan-V

Charles River EndoScan-V is a validated endotoxin detection and measuring software used to generate and report quantitative LAL test data. The endotoxin testing software performs requisite endotoxin calculations and generates secure data files and batch reports for product release as required by the FDA. All aspects of the software form the pillars of data integrity compliance according to 21 CFR Part 11: fully searchable audit trail, flexible user control and management, and reliable data generation and backup.
Find more information about Endosafe EndoScan-V here.

Charles River Cortex

Charles River Cortex provides an integrated solution to securely consolidate, query, and analyze all real-time endotoxin test data for necessary internal QA and FDA trending reports. The decentralized, multi-client solution provides complete QA/QC instrument oversight. This allows remote PC access (with Cortex client software installed) to the same results database and server. Cortex was designed in accordance with industry data integrity compliance guideline 21 CFR Part 11.
Find more information about Charles River Cortex here.