M-Trace® Electronic Test Record Software

The M-Trace^® Software & Mobile App is your 21 CFR Part 11 compliant Digital QC companion for Sterility Testing, for trusted and efficient data traceability! Watch the videos to learn more, and see how a fully traceable, reliable and efficient sterility test performed with the assistance of the M-Trace^® software could look like at your site.

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Experience a sterility test using the M-Trace^® solution

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Filling the gap in Sterility Testing: Traceability and 21 CFR Part 11 Compliance

By giving step-by-step guidance and recording data automatically in realtime, the M-Trace^® system offers a convenient and reliable way to comply with regulatory requirements regarding traceability and data integrity.

Connect the M-Trace^® software to your current Steritest^® Symbio pump(s)
Run the software from any computer using your centralized user management for Microsoft Windows
Benefit from enhanced 21 CFR part 11 compliance thanks to the audit trail function
Ensure full traceability and regulatory compliance from real-time, automatic, and complete recording of data for each of your sterility tests
Increase process safety with guided workflows and deviation alerts
Improve efficiency by eliminating paper-based documentation and digitizing recording and review processes
Facilitate automated control of your Steritest^® Symbio pump(s) and greater connectivity of your testing data to your lab IT environment (one single software to control all your pumps)
Simplify training of operators with comprehensive real time instructions

Get full control of your entire Sterility Testing workflow

Sterility Testing workflow creation with the M-Trace software

Get your Workflow Digitalized

Digitalize your SOPs by creating fully customizable Master Test Records (MTRs) that will guide you through the workflow.

Connect Data From Anywhere

Connect information on samples, consumables, test points or devices, and test results from the lab or anywhere with the M-Trace^® Mobile App.

Confirm by voice control all your Sterility testing steps

Validate any Method Step (e.g. using voice control function)

Confirm the proper execution of a work step either by voice control or by machine-to-machine communication to allow real time documentation while your hands are busy with other tasks.

Monitor Your Process

Obtain instrument parameters such as pump speed or pressure from instruments such as the Steritest® Symbio pump.

Generate automatically a digital test report of your sterility testing

Generate Comprehensive Reports

A comprehensive report is automatically created containing all information on consumables used, incidents that occurred, and confirmation that each work step has been carried out as defined.

Ensure Compliance

Define roles and user rights in the comprehensive and convenient 21 CFR part 11 compliant user management system.

DISCOVER M-TRACE^® ELECTRONIC TEST RECORD SOFTWARE

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Brochure: A deeper understanding of our M-Trace^® Electronic Test Record Software

Get more detailed information and learn how a fully traceable, reliable and efficient sterility test performed with the assistance of our M-Trace^® software could look like at your site.

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