Establish Confidence in Your Data

With the growing volume of quantitative LAL tests being performed every day, electronic data generation and secure retention is now an requirement, rather than an option. FDA warning letters and global guidance documents are increasing requirements on data integrity, making visible gaps and deficiencies in data and reporting practices across industries. EndoScan-V endotoxin testing and analysis software enables you to make informed, confident decisions on product quality through an integrated, all-encompassing data management infrastructure.

Data-driven decisions are the only way to confidently confirm product quality and ensure patient safety. Your endotoxin detection program and platform requires endotoxin testing software that generates accurate raw data analysis for reporting, tracking, and trending of BET testing, whether using LAL and rCR reagents.

A laptop displaying a list of data

Achieve More Consistency and Reliability​
​ Accessing accurate, relevant BET data in a simple organized platform is essential for confident, data-driven decisions. EndoScan-V features an intuitive interface for accessibility with secured backup protecting historical records to unlock real-time visibility into emerging trends in your results.
​ Review The Product Sheet

Power Data-Driven Investigations

The need to rapidly investigate Out-Of-Specification (OOS) results continues to be one of the most pressing GMP issues facing quality leaders. Data deficiencies lead to delays resolving product quality questions - while incomplete records draw scrutiny.

EndoScan-V Version 6 paired with Charles River Cortex™ tackles this challenge through an integrated software solution consolidating all endotoxin test data for rapid, simple querying. Robust functionality securely empowers investigations and trend reports providing real-time, auditable data visibility to uphold manufacturing integrity.

Although the general appearance looks similar to EndoScan-V version 4/ EndoScan-V version 5, EndoScan-V version 6 usability was greatly improved by adding several different features such as the accessories database for managing materials and equipment used. The accessories database links to all assays conducted which is extremely important in maintaining quality control within laboratory testing.

Quality Procurement, biotech industry, Finland

Endoscan-V Software Features

  • Enterprise-Level Capabilities
    • Backup and Restore functions eliminate the risk of data loss
    • Automatic data export functionality
    • Performs the requisite calculations and creates batch reports for product release
    • Flexible user control and management for controlling user access for how data is generated and stored
    • Fully searchable audit trail
    • Integrated digital signatures to electronically sign data reports for a paperless system
    • Reliable data generation and backup for retrieval of all data and settings if needed
  • Comprehensive Audit Trails
    • EndoScan-V’s Searchable Audit Trail can reconstruct critical elements of data generation, providing investigatory insights into unexpected events
    • Perform open keyword searches or leverage pre-defined critical action queries
    • Enable comments for Post Assay changes, Global Settings changes, and Digital Signature changes, allowing capture of the Why to the Who, What, and When of an audit trail
    • Print audit trail searches and manually sign for physical records
  • Proactive Backup
    • The PostGres database stores all data and configurations for regular automated backup
    • Scheduled backups facilitate complete, timely data recovery in the event of disasters or unexpected failures - eliminating risks of data loss
    • Automatically schedule database backups (minimum daily)
  • Unified Data Analytics through Cortex
    • Continuously monitor results to track and analyze trends for a complete state of control
    • Create custom alerts to address issues and simplify lab investigations
    • Gain complete QA/QC oversight, increase visibility into key performance indicators, and proactively manage the operational integrity of your equipment fleet
    • Securely consolidate and analyze all LAL and rCR testing data in real time for necessary internal QA and FDA trending reports, effortlessly elevating your compliance status
    • Compile data for unified data infrastructure
    • Proactively manage and monitor the operational performance of the entire facility’s equipment fleet including component effectiveness, calibration schedules, and system readiness
    • Identify inconsistencies and deviations early for faster investigations and remediations
  • Scalable LIMS Connectivity

    EndoScan-V enables efficient transmitting of data files to centralized databases including LIMS and Cortex through automatic exports via secure XML or CSV format.

  • Reinforced 21 CFR Part 11 Compliance

    EndoScan-V reinforces compliance and security through:

    • Integrated digital signature option permits document review and sign off
    • Implement, integrate, and comply with data integrity guidelines globally
    • Digitally sign test records for all data including cartridges

     

    User Access Controls

    • All settings and actions are attributed to a privilege in EndoScan-V
    • Establish flexible security policies by user group for enabling or restricting access throughout software
    • Requires a username and password for each user for additional security
    • Auto-lock function engages during user inactivity while tests continue to run
    • Configure users, roles, report styles, and other settings

Endoscan-V Software Tutorials

View our tutorials to get a preview of software functionality and configurability

  • Product Codes
    EndoScan-V™ - Software

    M1260

    EndoScan-V™ Client Manager

    M1261

     Endoscan-V™ Software Validation Package

     TS600

EndoScan-V Device in use

EndoScan-V Supported Test Methods and Systems​
​ Our suite of scalable Endosafe® bacterial endotoxin detection systems support a variety of testing techniques, sample type, and volumes to address different industries and testing requirements.
​ View The Endosafe Systems

Frequently Asked Questions (FAQs) About Endotoxin Testing Software

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