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®
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)
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
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
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
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- No more outdated SOP review, CAPAs or team training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
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!
We would love hear from you and show you our solution.