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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 and other regulated processes for trusted and efficient data recording!

  • Ensure full traceability and regulatory compliance from real-time, automatic, and complete recording of data for each of your QC tests 
  • Increase process safety with guided QC 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 and greater connectivity of your testing data to your lab IT environment
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Features

Sterility Testing workflow creation with the M-Trace software

Create Custom Workflows

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

    M-Trace<sup>®</sup> mobile app

    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

      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.

        Obtain Steritest Symbio pump parameters to 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

          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.

            21 CFR part 11 compliant user management system

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

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              Related Product Resources

              Mtrace Brochure
              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. 

              Download Now

              Mtrace Datasheet
              Datasheet: Technical information about our M-Trace® solution

              Get additional technical information about your digital QC companion for sterility testing and other regulated processes.

              Download Now 

              Mtrace Software
              Whitepaper: M-Trace® Electronic Test Record Software and regulatory compliance

              Get access to the detailed analysis related to 21 CFR Part 11 compliance of our M-Trace® software.

              Download Now 

              Related Technical Resources
              Steritest® NEO Membrane Filtration Sterility Test
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              Sterility Testing Culture Media & Rinsing Fluids
              Our sterility testing media and fluids are formulated and tested to meet EU, US, and JP pharmacopeia regulations, and are supplied with full certification containing pH, sterility, and growth promotion information.
              Sterility Testing by Direct Inoculation
              Direct inoculation of culture media is the method of choice for sterility testing of non-filterable samples. Select from our range of sterility testing media including soybean casein digest medium (TSB), and Fluid Thioglycollate medium (FTM standard and clear).
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              The user-friendly Steritest® Symbio pumps and accessories are designed for easy and reliable sterility testing. The system improves your workflow and maximizes safety, confidence, and convenience.
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              Steritest® NEO device is ideal for sterility testing of antibiotics. The Steridilutor® NEO system is designed to dissolve and dilute drugs in vials whereas the Steridilutor® NEO device for the liquid transfer kit allows diluting liquids from open ampoules into a septum-equipped diluent container.
              Sterility Testing of Products to be Diluted in Isopropyl Myristate
              The combination of Sterile Isopropyl Myristate (IPM) and the Steritest® NEO device is an effective solution for sterility testing of viscous products like creams and ointments. IPM enhances sample filterability by diluting these products.
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