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 exceedings industry data integrity compliance guidelines according to 21 CFR Part 11, 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.
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.
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 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.
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
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What testing instruments can be used with endotoxin testing software created by Charles River?
EndoScan-V™ version 6.0 is compatible with the BioTek® ELx808IU microplate reader, Endosafe® -MCS™ and Endosafe® nexgen-MCS™, Endosafe® -PTS™ and Endosafe® nexgen-PTS™ instruments.
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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® instruments require EndoScan-V™ as the driver to use Cortex™.
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Why is data integrity compliance currently 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.