TraceX is an open-source electronic Quality Management System (eQMS) designed to help healthcare, medical device, and regulated industry teams manage quality processes, technical documentation, and compliance obligations in one platform. It offers specialized modules for regulatory needs while retaining collaboration and lifecycle management features.
What does TraceX do?
TraceX supports teams in meeting international and national regulations such as EU MDR, FDA 21 CFR Part 11, ISO 13485, and ISO 14971. It combines document control, training records, risk management, audit preparation, and product lifecycle management. It is built on the Huly open-source platform, so users benefit from transparency, adaptability, and long-term sustainability.
By using open-source code, organizations retain access and control over their compliance data and can continue development or support even if the original vendor is unavailable.
What are the main features?
Electronic Quality Management
- Version control for documents with audit trails
- Approval workflows and electronic signatures
- Training tracking and risk management tools
- Preparation aids for regulatory audits
Product Lifecycle Management
- Tracking from concept through market release and post‑market surveillance
- Design control, requirements specification, verification, and validation
- Compliance checkpoints at every stage
Collaboration Tools
- Real‑time chat and videoconferencing
- Task management and file sharing
- Virtual office environment
Partner Network
Through its partner marketplace, TraceX connects companies to consultants offering QMS setup, regulatory updates, PRRC services, templates, and validation packages.
AI Assistant
Hulia, the integrated AI assistant, automates routine compliance tasks, offers insights, and supports collaboration.
Hosting and Data Security
Data is hosted in ISO 27001-certified facilities in Germany with GDPR compliance. Automated backups run every 12 hours, with incremental backups capturing ongoing changes. Advanced protection uses Cloudflare services.
Integration and API
TraceX has bidirectional synchronization with GitHub and an open API for connecting to other systems. Additional integrations are planned for Jira, Azure DevOps, and more.
Who should use TraceX?
TraceX is intended for startups, consultants, and established companies in regulated industries, especially healthcare and medical device manufacturing. It is suitable for organizations that need to maintain detailed quality records, pass audits, and coordinate cross‑functional teams across product development and post‑market activities.
FAQ
- Can TraceX be self‑hosted?
Yes. Organizations can run TraceX on their own servers or use the SaaS version hosted by TraceX. - Does it include QMS templates?
Templates are available from partner consultants and are tailored for multiple standards. - How is validation handled?
Partners offer installation, operational, and performance qualification packages for TraceX. - Is data encrypted end‑to‑end?
Currently encryption is applied in transit with HTTPS and at rest on hosting servers. Plans are in place for full end‑to‑end encryption in future versions. - Which regulations are supported?
TraceX is designed to work with any regulatory framework or localization requirement.
Conclusion
TraceX combines open-source flexibility with compliance‑focused features for regulated sectors. For medical device and healthcare teams, it offers an adaptable solution to manage documentation, product lifecycles, and regulatory requirements within one secure environment.
Disclaimer
This article is for informational purposes only and has no affiliation with the developers or publishers of TraceX.