Charles River Cortex™

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.

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.

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.

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.

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.

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.

• 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 Study 1: Intermittent Low Spike Recovery?
• Case Study 2: Trending Invalids and Retests
• Case Study 3: Evaluating High Sample Endo Value Over Time
• Case Study 4: Analyzing Differences Between Operators

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.

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.

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.