What is TraceX?

TraceX is a free, open-source eQMS built on top of the Huly platform designed for managing end-to-end creation of medical devices.

TraceX contains eQMS features, including documentation management, electronic signature (21 CFR part 11, FDA), PDF export, and product management. All of the project management features available in Huly are also included in TraceX, including task tracking, virtual office, chat and wiki docs.

This documentation covers eQMS features unique to TraceX. For more information, visit TraceX.co.

TraceX features

In addition to the project management features available in Huly, TraceX includes the following unique eQMS features:

• Roles & permissions
• Products
• Trainings
• Controlled document types
  • Templates
  • Quality documents
  • Technical documentation
• Controlled document authoring
  • Editing & formatting
  • Additional settings
  • Document versions
  • Ownership & authorship
• Reviewing and approving with electronic signatures
• Filtering documents

TraceX also includes the following features and modules available in Huly:

• Task tracking
• Chat
• Virtual office (including video conferencing)
• Documents

Getting started

New to TraceX? Check out our workspace setup guide to get started!

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Feeling stuck?

We’re here to help! If you need help along the way, our Slack community is a welcoming space for you to connect with our team, ask questions and meet other TraceX users. After joining the community, head over to the #tracex channel. We hope to see you there!