Endotoxin Analysis Software for Investigative Evaluation & Process Monitoring

One of the first elements of any regulatory audit is to analyze and scrutinize a firm's investigation reports and review how they control their manufacturing and laboratory processes. Considering this, it is critically important for patient safety as well as quality compliance that both investigations and how the firm demonstrates process control is done right the first time.

Charles River Cortex is an all-encompassing endotoxin analysis software platform for data and instrument management, investigation analysis, and process monitoring. This software empowers you to make informed, confident decisions while maintaining a centralized state of control.

You're supposed to run your facility,
not the other way around.

Charles River Cortex on laptopConcerned about maintaining your data integrity compliance status? Managing your equipment? Upcoming regulatory inspections? Take control of your equipment, data, and reporting.

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The Impact of Charles River Cortex Software on Endotoxin Analysis Methods

Maintaining the long-term safety of a manufacturing environment while meeting the demands of compliance is a microbial quality control manager's top priority. The need to investigate OOS results continues to be one of the most commonly observed cGMP issues during quality control laboratory inspections, so having access to accurate, relevant, and reliable data is essential to support confident decisions on product quality.

Charles River Cortex software excels at endotoxin analysis, enabling users to make informed, confident decisions through an integrated, all-encompassing test management infrastructure while maintaining a complete state of control. Cortex meets current global data integrity standards and consolidates all endotoxin analysis data for necessary internal QA and FDA trending reports to mitigate the risk of data integrity violations.

Cortex Supported Products


The full suite of Endosafe®️ bacterial endotoxin testing instruments, the Endosafe®️ nexgen-PTS, the Endosafe®️ nexgen-MCS and the Endosafe®️ NexusOur endotoxin testing equipment reduces variability and increases operational efficiencies by achieving quantitative results and incorporating flexible configuration capabilities.

View Endosafe® Testing Equipment

Transform Analytical Data into Actionable Results

You’ll be able to make confident decisions when you analyze your endotoxin testing data with Charles River Cortex. With this software, you get:

  • Real-Time Tracking and Trending

    cortex offers real-time tracking and trending

    A Proactive Approach to Risk Management

    Tracking and trending QC data is a proactive approach to risk management. With the ability to continuously monitor endotoxin results while using Cortex software, users can:

    • Track and analyze trends in real time to address inconsistencies in data and maintain a complete state of control throughout the manufacturing facility.
    • Statistically perform endotoxin analysis on data sets and calculate average, median, or standard deviation for multiple data sets and data generating platforms.
    • Facilitate trending on operator statistics to analyze performance based on the test suitability column from cartridge data.
  • Custom Alerts with Cortex Endotoxin Analysis Software

    cortex features custom alerts

    Your Rules, Your Ranges

    • Send emails when the system detects deviations from set rules and ranges (e.g., invalid test criteria or test failures) for Endosafe nexgen systems. This supports real-time data generation of critical in-process testing.
    • Determine action and alert limits and generate emails for incoming data based on rule sets.
    • Deliver instant peace of mind during endotoxin analysis by alerting users to a developing issue.
  • Operational Management of Equipment Fleet

    cortex for Operational Management of Equipment Fleet

    Manage, Monitor, Approve

    • Interface with Endosafe rapid testing systems, microplate readers, and tube readers.
    • Monitor, approve, and track equipment performance, and bring together all relevant operational data from within the same framework when executing endotoxin analysis.
    • Manage and harmonize your Endosafe nexgen-PTS devices with Cortex endotoxin analysis software by creating a sample database, developing device users, scheduling calibration dates, and disabling devices that have passed calibration dates.
  • Automatic Data Imports

    cortex offers Endotoxin Analysis Software Data Import

    Endotoxin Analysis Software Data Import

    • For systems that require EndoScan-V™ endotoxin analysis software as the data driver, Cortex software can automatically import the exported data from version 5.5.4 and higher.
    • Raw data files will remain with the EndoScan-V as will the audit trails for the data generated.
    • Electronic signatures for plate and tube reader data can be implemented from within EndoScan-V.
    • Electronic signatures for cartridge-based data generated in EndoScan-V can be electronically signed in either EndoScan-V or Cortex software.
  • A Robust Audit Trail

    cortex offers Reassurance at a Glance

    Reassurance at a Glance

    • With Cortex software, integrate your endotoxin analysis data with a solution that breaks down data silos and addresses today’s data problems while there's time to correct them.
    • Secure e-signatures and action tracking within the audit trail supports improving compliance with data integrity standards.
    • Digitally sign and include comments in Cortex Software to Endosafe nexgen cartridge systems test records to maintain data integrity and achieve compliance with 21 CFR Part 11.
  • Three Levels of User Management Profiles

    cortex offers Data Integrity Compliance

    21 CFR Part 11 and Data Integrity Compliance

    • Cortex endotoxin analysis software includes three levels of user management profiles to allow users to establish and grant appropriate access to operators:
      Administrators may access to the entire platform, including setup and setting changes.
      Managers may access the product database and configure operators.
      Users may view and print reports.
    • Password protection adds an extra level of security, prompting for login credentials before accessing and performing functions.
    • The Cortex server/client platform permits restoration of databases through backup and restore functionality.

 

Features and Benefits

  • Cortex Features and Benefits
    • Maintain a complete state of control through real-time tracking and trending.
    • Continuously monitor endotoxin results and create custom rule-based email alerts to address issues and simplify lab investigations.
    • Meet current global data integrity guidance standards and elevate compliance position
    • Gain complete QA/QC oversight, increase visibility into key performance indicators
    • Proactively manage the operational integrity of your equipment fleet.
    • Securely consolidate and analyze all endotoxin data in real-time for necessary internal QA and FDA trending reports to elevate effortlessly your compliance status.
    • Increase security with user management profiles.
    • Search audit log.
    • Achieve efficient LAL testing operations.
    • Integrate EndoScan-V version 5.5.4 and higher.
    • E-sign for all Endosafe cartridge instruments.

Case Studies

Product Codes

  • Cortex Product Codes
    Product Code
    Charles River Cortex Software M1600
    Charles River Cortex License/Device Authorization
    per Endosafe-PTS (PTS100K) device
    M1601
    Charles River Cortex License/Device Authorization
    per Endosafe nexgen-PTS (PTS150K) device
    M1602
    Charles River Cortex License/Device Authorization
    per Endosafe MCS (MCS100K)
    M1603
    Charles River Cortex License/Device Authorization
    per Endosafe nexgen-MCS (MCS150K)
    M1604
    Charles River Cortex License/Device Authorization
    for Plate Reader/Tube Reader
    M1605
    Charles River Cortex IQ/OQ Service AMC502S

 

Frequently Asked Questions (FAQs) About Cortex Software

  • Do you need to have Endosafe EndoScan-V to use Charles River Cortex software?

    No, the Charles River Cortex software can be used with either EndoScan-V or the Endosafe nexgen-PTS as a standalone instrument. The Cortex and Endosafe EndoScan-V™ together provide an integrated solution to securely consolidate, query, and analyze data for necessary internal QA and FDA trending reports.

  • Can Charles River Cortex software assist with my endotoxin analysis?

    Yes. The software is designed specifically for all of your endotoxin analysis needs. Cortex will help you transform your data into actionable results from your endotoxin analysis through accurate and reliable out-of-specification (OOS) investigations. The Charles River Cortex software also enables you to continuously monitor your endotoxin results through custom alerts to address issues immediately.

  • What are the endotoxin analysis methods?

    Both the Endosafe EndoScan-V and Charles River Cortex software are methods for performing an endotoxin analysis. Endotoxin analysis can be used to approve and monitor performance as well as consolidate data within the same framework. The Cortex software is equipped with real-time tracking and trending capabilities and statistical analysis features that include average, median, or standard deviation calculations on multiple data sets. These methods can be applied to the various kinetic endotoxin methods, such as turbidimetric, chromogenic, and LAL cartridges, whereas gel-clot cannot due to its qualitative characteristics.