How confident are you in the accuracy and security of your release testing data?

With over 70 million LAL tests being performed every year, it is now a requirement to ensure that electronic data generation is secure and reliable. FDA warning letters and new global guidance documents communicate the increasing requirements on data integrity, making many organizations aware of existing gaps and deficiencies in their data and reporting. Accurate and timely results are critical to ensuring your laboratory and manufacturing processes stay in a state of constant control.

Upcoming Webinar

Using Six Sigma Tools for OOS Investigations

Scientists working at the laboratory

Learn about the Six Sigma principles and how their use in OOS investigations can lead you to understand your processes better, allow for more efficient OOS investigations, enable you to drive to the true root cause, and ultimately lead to increased patient safety for your products.

Thursday, October 31
11:00 AM - 12:00 PM EDT
Reserve Your Seat

Could you achieve more consistency and reliability
 if you had better control over your testing data?

EndoSafe V client manager software viewed on a laptopHaving access to accurate, relevant, and reliable data is essential to support confident decisions on product quality.

Download the Product Sheet

Data-driven decisions are the only way to confidently confirm product quality and ensure patient safety.

Your endotoxin detection platform requires software that generates accurate raw data analysis for reporting, tracking, and trending of LAL testing. And the need to investigate out-of-specification (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.

EndoScan-V™ version 6 paired with Charles River Cortex™ can provide an integrated solution to securely consolidate, query, and analyze data for necessary internal QA and FDA trending reports.
 

EndoScan-V™

  • Version 6 Features
    1. Eliminate the risk of data loss of your endotoxin testing data with the Backup and Restore functions of the database.
       
    2. EndoScan-V™  endotoxin testing software allows you to make informed, confident decisions through an integrated, all-encompassing endotoxin test management infrastructure.
       
    3. EndoScan-V™  meets current global data integrity guidance standards through digital signatures, searchable audit trails, and comprehensive user management.
       

    EndoScan-V™ and Cortex™ Features

    1. Maintain a complete state of control through real-time tracking and trending.
       
    2. Continuously monitor endotoxin results and create custom alerts to address issues and simplify lab investigations.
       
    3. Gain complete QA/QC oversight, increase visibility into key performance indicators, and proactively manage the operational integrity of your equipment fleet.
       
    4. EndoScan-V™  securely consolidates and analyzes all LAL testing data in real time for necessary internal QA and FDA trending reports, effortlessly elevating your compliance status.

       

Data Integrity

  • Audit Trails, Backup, and Restore Capabilities
    1. EndoScan-V™  offers a Searchable Audit Trail, which allows the ability to reconstruct critical elements of data generation, gives firms more insight into the investigative process during unexpected events, and ultimately ensures compliance with data integrity standards.
       
    2. Search using open keyword or pre-defined searches for critical actions.
       
    3. Switch on comments for Post Assay changes, Global Settings changes, and Digital Signature changes allows the company to capture the Why to the Who, What, and When of an audit trail. This enables a reconstruction of all events if necessary.
       
    4. In EndoScan-V™  audit trail searches can be printed and manually signed.
       
    5. All data and global settings are stored within a PostGres database where a regularly scheduled backup can be set to ensure retrieval of all data and settings if needed. This ensures easy data recovery in the event of a disaster or other unexpected event occurs, eliminating the risk for unacceptable data loss.
       
    6. Automatically schedule database backups (minimum daily).


    Data Integrity Tutorials

LIMS Compatibility

21 CFR Part 11 Compliance

  • Digital Signature & User Management


    Digital Signature

    • The integrated digital signature option in EndoScan-V™  endotoxin testing software permits document review and sign off.
       
    • Implement, integrate, and comply with data integrity guidelines globally.
       
    • Digitally sign test records for all data with EndoScan-V™ and cartridge data.
       

    Digital Signature Tutorials


    User Management

    User management is about controlling user access to how data is generated and stored. It is critical for conforming to data integrity.
     

    • All of the settings and actions are attributed to a privilege in EndoScan-V™.
       
    • Privilege groups can be established so flexibility within user access to any part of the software can be as restrictive or open as needed.
       
    • For additional security each user requires a username and password.
       
    • EndoScan-V™ endotoxin testing software includes an automatic lock function when no activity occurs for a specified time while the test continues to run in the background.
       
    • Configure users, roles, report styles, and other settings.


    User Management Tutorials
    EndoScan-V™ version 6.0 User Management

Tutorials

EndoScan-V™ Supported Products

Lab where QC on LAL reagents is conductedOur endotoxin testing equipment reduces variability and increases operational efficiencies by achieving quantitative results and incorporating flexible configuration capabilities.
 

View Endosafe® testing equipment