Data Integrity-Compliant Ready Software

Our 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

Your endotoxin detection platform requires testing software that generates accurate raw data analysis for reporting, tracking, and trending. Accurate and timely results are critical to ensuring your laboratory and manufacturing processes stay in a state of constant control. EndoScan-V is a validated endotoxin detection and measuring software used to generate and report quantitative LAL test data.

technician using 21 CFR part 11 compliant Endosafe® EndoScan-V endotoxin testing software

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.

"As a leading pharmaceutical company, we are really concerned about GMP and data integrity compliance, therefore, it is mandatory that a critical analysis like endotoxin testing is performed with a software which complies with regulations. EndoScan-V version 6 has increased data integrity with reliable and trackable data."
Microbiology Technician, global healthcare industry, Barcelona

Charles River Cortex

Concerned about maintaining your data integrity compliance status? Managing your equipment? Upcoming regulatory inspections? Take control of your equipment, data, and reporting with 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.

technician using 21 CFR part 11 compliant Charles River Cortex™ tracking and trending endotoxin testing software

Customers can compile and manage data from any of the Endosafe rapid testing platforms, microplate readers, and tube readers into a unified data infrastructure to gain complete insight on their manufacturing operation and process in order to make informed, confident decisions.

Cortex allows users to proactively manage and monitor the operational integrity of the entire facility's endotoxin instrument equipment fleet including component effectiveness, calibration schedules, and system readiness within a single, end-to-end risk management environment. Cortex was designed in accordance with industry data integrity compliance guideline 21 CFR Part 11.

Frequently Asked Questions (FAQs) About Endotoxin Testing Software