The future of eQMS is free

TraceX is the first free of charge and open-source eQMS to manage end-to-end creation of medical devices.

TraceX eQMS is powered by Huly®



Enjoy a tour!

TraceX contains eQMS features, like fully online documentation management, digital signature (21 CFR part 11, FDA compliant), PDF export, product management.

TraceX is also much more than a simple eQMS as it also includes project management features like a task manager (like
Jira), a visio (like Zoom), a virtual office (like Roam), a chat (like Slack) and a wiki (like Notion)

TraceX next generation eQMS includes a Task Tracker like Jira. Elevate compliance and software development efficiency.

Create technical documentation with the click of a button

Documents (Traceability Matrix, test reports, requirements and specifications) are automatically generated from the integrated task tracker:

- Remove double entries for documentation purposes
- Reduce the risk of mistakes or typos
in documentation creation
- Empower your team
to work more efficiently

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Stop wasting time on trivial tasks

The QARA team spends a lot of time reviewing documents. TraceX makes it easy to focus on what's important by eliminating mundane tasks:

- No more version issues
- No more formatting issues
- No more lack of traceability
- No more chasing nor missing signatories


TraceX is fully integrated with your day-to-day tools

No need to ask your dev team to change their tools. With 2 options available you can enjoy the full capability of TraceX:

1. Continue using your day-to-day task tracker and testing tools (e.g. GitHub, Jira, X-ray, Azure DevOps, ...) while integrating with TraceX eQMS
2. Use our integrated Task Tracker


Your audits become a piece of cake!

With TraceX, everything is tracked, and teams get reminders if they don't complete their activities on time. Stop spending weeks prior to an audit to review and fixing everything:

- No more outdated SOP review, CAPAs or team training
- Everything is easily exportable to pdf format with the click of a button
- Reduce the stress prior to audits


No need to choose between tool price and efficiency

With TraceX, we offer a modern, easy to use, complete solution free of charge!

TraceX eQMS is the first all-in-one and free of charge Solution that addresses both project efficiency and regulatory compliance!


Unleash your capabilities with TraceX eQMS

  • No more paper nor Microsoft Word based approach. TraceX is a New Generation, fully digital eQMS (electronic Quality Management System) that enables you to track Quality Events, Training / Qualification, Documentation Control and ensure compliance.
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    Benefit fully from the TraceX integrated Task Tracker

  • No need for an additional tool to manage tasks to build your medical software. TraceX provides you with a Task Tracker (like Jira) fully integrated with the eQMS.
  • Learn More
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    Can the TraceX eQMS integrate with Jira and generate documentation automatically?

    Yes, with TraceX you only need to enter your data once in the Task Tracker (TraceX integrates with any other tool). Through APIs, you can easily generate documents in TraceX eQMS based on information entered in the Task Tracker (Traceability Matrix, test reports, requirements, specifications, etc). This capability saves a lot of time and mistakes.

    How can TraceX eQMS be free of charge? What is TraceX business model?

    We are a business broker (business introducer) between our expert partners and medtechs.

    How long does it take to implement the solution in my company?

    It depends on you and your pace as this is a collaborative activity but in general, for the TraceX custom configuration, the upload of documents (SOP, etc.), and the TraceX validation, it takes a couple of weeks. The sooner you're able to use the tool the happier we are!

    Are there additional costs to implement TraceX?

    No, the entire onboarding and setup are at no extra cost!

    Do you also provide consultancy to implement a QMS?

    Yes, we can also help you in that matter. With our QARA Network, we can provide quality and regulatory expertise. From this website menu, please refer to solutions > QARA Consulting Services.

    Do you have QMS template we can use to set up our QMS?

    Yes, we can help you with this tool. With our QARA Network, we can provide quality documentation templates (e.g. SOP, forms) for your usage. From this website menu, please refer to solutions > QARA Consulting Services.

    Want more information?

    We would love hear from you and show you our solution.

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