EndoScan-V™

Endotoxin Measuring & Analysis Software

EndoScan-V™ is an endotoxin measuring and analysis software utilized to generate and report quantitative LAL test data. Verified and validated to be consistent with FDA requirements, the program performs the requisite calculations and creates batch reports for product release. For added protection, it generates secure data files and audit trails on all actions involving files and test data. The program was designed with flexible configuration capabilities and performance options for gaining operational efficiencies. Fully compliant with 21 CFR Part 11 regulations for electronic records, the software allows users to adhere to data integrity guidelines on site.

Software Features

• Validated on Windows 7 and 10
• Click-and-drag functions for fast and easy template setup
• Auto-archiving for audit trail
• Barcoding and automatic export functions for data export to Excel or LIMS
• Meets current global data integrity guidance standards and elevates compliance position
• Increased security and data integrity with user management profiles
• User-defined database selection of validated test parameters
• Ability to generate secure data files and audit trails on all actions involving test data
• Compatible with Endosafe^® instruments and a variety of microplates and readers (Biotek Elx808, Tecan Sunrise, and ATi tube readers)
• Integrates into Charles River Cortex™, our all-encompassing endotoxin software platform for data and instrument management, investigation analysis, and process monitoring
• Automatically calculates the amount of endotoxin recovered in the PPC and compares it to the known amount of the endotoxin in the well to provide the user a percentage of recovery

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