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    The future of eQMS is free


    The first free, open-source eQMS designed to improve the efficiency of your medical device lifecycle.

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    Enjoy a quick 2-minute TraceX video

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    TraceX is an all-in-one solution for medtech & biotech companies.

    TraceX contains eQMS features, including documentation management, electronic signature (21 CFR part 11, FDA compliant), PDF export, product management, and training & qualification.

    In addition to these eQMS features, TraceX is considered as an all-in-one solution as it also includes everything you need to collaborate:     requirements & task manager (like Jira), video conferencing (like Zoom), virtual office (like Roam), chat (like Slack), wiki (like Notion) and more.

    TraceX is unique

    Free of charge software & marketplace

    TraceX software is free of charge with unlimited users and unlimited features.

    Our business model is through a marketplace alongside the product.

    On that marketplace you can find any products and services you might need for your Medical Device (e.g. Quality, Regulatory, Human Factors Engineering (HFE), Engineering, Cybersecurity, Risks, Product, Testers, ...)

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    Open-source software

    Because TraceX is open-source, there are many additional benefits for clients.

    Transparency: Clients can audit the software for security vulnerabilities, ensuring that no malicious code or backdoors exist.

    Security: TraceX is supported by a large community of developers who continuously review, test, and enhance the software, resulting in higher security standards and faster vulnerability detection.

    Availability: Because the source code is available, clients can maintain and update the software for as long as needed, even if the original developers or vendors discontinue support.

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    Self-hosted or SaaS

    We support both self-hosted and Saas methods for TraceX, so you can choose the option that best suits your needs.

    Self-hosted: You host and manage the software on your own servers.

    SaaS: The software is hosted and managed by TraceX and hosting provider.

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    Real-time collaboration on controlled documents

    TraceX allows multiple users to work simultaneously on shared documents, with updates and changes being instantly visible to all collaborators.

    Controlled documents also include version control and access management features, ensuring that only authorized individuals can edit or modify the content.

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    Two-way GitHub sync

    TraceX is built on top of Huly® platform which means, in addition to the eQMS features, it includes all project management features available in Huly (e.g. task tracker, virtual office, chat, wiki).

    GitHub integration is also available and enables to manage your tasks efficiently with our bidirectional GitHub synchronization.

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    TraceX eQMS next gen

  • TraceX eQMS will improve efficiency and quality with real-time collaboration on controlled documents, electronic signature (21 CFR part 11, FDA compliant), PDF export, product management and training & qualification.
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    TraceX requirements management

  • TraceX is an all-in-one solution and also includes requirements & task manager (like Jira), video conferencing (like Zoom), virtual office (like Roam), chat (like Slack), wiki (like Notion) and more
    • Learn more
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    FAQ

    Is there any integration between TraceX and other systems?

    Yes, TraceX is synced both ways with GitHub. You can manage your tasks efficiently with our bidirectional GitHub synchronization.
    You can use TraceX as an advanced front-end for GitHub Issues and GitHub Projects.

    In addition, we are also working on various integrations coming soon (e.g. Jira, X-ray, Azure DevOps, ...)

    Your team can also use our open API to connect to other tools your company might be using.

    Is TraceX eQMS really free of charge? How is it possible?

    Yes, TraceX product is free of charge with unlimited users and unlimited features.

    Our revenue is made through a marketplace alongside the product.

    On that marketplace you can find any products and services you might need for your Medical Device creation (e.g. Quality, Regulatory, Human Factors Engineering (HFE), Engineering, Cybersecurity, Risks, Product, Testers, ...)

    Using the marketplace is not required, however, and even if you choose not to use products and services from the marketplace you can still use TraceX for free.

    During the onboarding phase, how can we avoid the long and repetitive task of importing our current documents and converting them into a digital format compatible with TraceX?

    We can do it for you!

    We have developed a document import & conversion tool, so we can automatically import and convert your documents into TraceX in the right format.

    Is it possible to self host our data?

    Yes, we support both self-hosted and Saas methods for TraceX, so you can choose the option that best suits your needs.

    Self-hosted: You host and manage the software on your own servers.

    SaaS: The software is hosted and managed by TraceX and hosting provider.

    Do you also provide consultancy to set up a QMS?

    Yes, you will be able to find in our marketplace our partners with specific expertise and Quality & Regulatory is one of them.

    As the marketplace is not built yet, please ask us directly what you need and we will be able to guide you within our network of expert partners.

    For more more information, please see: https://tracex.co/qara-consulting-services

    Do you have QMS templates (e.g. Work Instructions, Procedures, ...) we can use to set up our QMS?

    Yes, you will be able to find in our marketplace partners who have templates available.

    As the marketplace is not built yet, please ask us directly what you need and we will be able to guide you to the right people.

    For more more information, please see: https://tracex.co/qara-consulting-services

    Is open-source software less secure than closed-source?

    Because TraceX is open-source, there are many additional benefits for clients.

    Transparency: Clients can audit the software for security vulnerabilities, ensuring that no malicious code or backdoors exist.

    Security: TraceX is supported by a large community of developers who continuously review, test, and enhance the software, resulting in higher security standards and faster vulnerability detection.

    Availability: Because the source code is available, clients can maintain and update the software for as long as needed, even if the original developers or vendors discontinue support.

    Do you provide validation package? As a critical supplier, we need to validate an eQMS which can be very time consuming.

    Yes, we are aware of that and to help you, we have created a validation package.

    We help you for your next audits to show that we comply with international regulations, e.g. ISO 13485, IEC 62304, 21 CFR part 11 (FDA).

    Want to know more?

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