Improve Data Integrity for Confident Endotoxin Testing
Our endotoxin testing software solutions empower laboratories to reduce variability and enhance productivity through digitized test workflows, transparent data oversight, and centralized trend analysis. By aligning with current data integrity guidelines per FDA 21 CFR Part 11, both Endosafe® EndoScan-V™ and Charles River Cortex™ establish the technical controls and traceability required for product release testing and continuous process improvements.
Endosafe® EndoScan-V™: Reliable Endotoxin Quantification
EndoScan-V is our foundational secure endotoxin analysis software for generating and reporting quantitative LAL and rCR test data, forming the pillars of data integrity compliance according to 21 CFR Part 11. Compatible with all Endosafe® systems, Endoscan-V securely analyzes, calculates, compiles, and stores bacterial endotoxin testing results with full audit trails for retrospective searches. Version 6.1 and above now includes active directory functionality which allows users to utilize their Windows and network login criteria with EndoScan-V for secure, streamlined access.
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
Charles River Cortex™: Unified Data Ecosystem
Charles River Cortex is an integrated consolidated data ecosystem designed to optimize endotoxin testing workflows by networking all Endosafe instruments onto a unified platform for seamless data synchronization and remote oversight. Core capabilities include centralized remote access allowing on-demand instrument and critical test data analysis; automated compilation of results into reports to support internal and external audits, eliminating manual reporting; as well as multi-site scalability to connect global facilities for complete process monitoring. By consolidating separated systems onto an enterprise-level platform, Charles River Cortex enables labs to transform disconnected results data into connected insights.
Frequently Asked Questions (FAQs) About Endotoxin Testing Software
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What testing instruments can be used with endotoxin testing software created by Charles River?
Endosafe EndoScan-V version Compatibility Version 6.0 and higher BioTek ELx808IU microplate reader (LAL)
Version 6.2 and higher BioTek ELx808IU microplate reader (rCR)
Version 6.2 and higher Endosafe® PRS3 microplate reader (LAL & rCR)
Version 6.1 and lower Endosafe-MCS™ (LAL & rCR)
Version 6.0 and higher Endosafe® nexgen-MCS™ (LAL)
Version 6.2 and higher Endosafe® nexgen-MCS™ (rCR)
Version 6.1 and lower Endosafe-PTS™ (LAL & rCR)
Version 6.0 and higher Version 6.2 and higher Version 6.0 and higher Endosafe® Nexus 200™(LAL)
Version 6.2 and higher Endosafe® Nexus 200™(rCR)
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Do you need to have EndoScan-V to use Charles River Cortex?
You can use Cortex with the Endosafe nexgen-PTS as a standalone instrument. All other Endosafe systems require EndoScan-V software to use Cortex for consolidated data tracking.
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Why is data integrity compliance such a hot topic with endotoxin testing software?
The FDA and other global regulatory agencies want to improve drug quality and patient safety through vigilant oversight of data at pharmaceutical manufacturers. Data integrity controls ensure the accuracy of the data the regulatory agencies want to see. Find out more about data integrity compliance and 21 CFR Part 11.
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Which Charles River endotoxin testing software can be used for tracking and trending my endotoxin test data?
Charles River Cortex allows you to transform analytical data into actionable results with real-time tracking and trending.
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Where do I find more information?
You may find more information on our Endosafe technical resources page.