Is TraceX eQMS really free of charge?
Yes, TraceX offers a free plan that provides companies with access to a powerful, AI-powered compliance platform at no cost up to a certain usage level.
Our goal is to make regulatory compliance tools accessible to as many companies as possible. However, to ensure sustainability and continued innovation, we’ve implemented usage-based tiers beyond the free plan. These tiers help us protect the platform while providing advanced features and additional support to companies with more complex needs.
For full details on our pricing and usage limits, visit our Pricing Page. As an open-source platform, what happens if TraceX disappears?
With TraceX, you’re never locked into a proprietary system. As an open-source platform, the source code is publicly available, meaning the platform can be maintained, improved, or adapted by any developer or partner, ensuring its long-term sustainability.
In terms of your data, it is securely hosted by our third-party hosting provider. Even if we were to disappear, your data remains yours, and you would retain access to it. Our partners can help you export or migrate your data to another system, ensuring you never lose control of your critical compliance information.
In short, TraceX is built to last, and your data remains safe, secure, and accessible even in the unlikely event that our company ceases operations.
Is open-source software less secure than proprietary systems?
No, this is actually the opposite, open-source softwares are much more secure than proprietary systems.
Because TraceX is open-source, there are many additional benefits for users.
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.
How can we avoid the time-consuming task of importing and converting our existing documents into a digital format for TraceX during onboarding?
We’ve got you covered!
To save you time and effort, we’ve developed a document import and conversion tool that can automatically import your current documents and convert them into a format compatible with TraceX.
Our tool ensures a smooth onboarding process by handling the bulk import and format conversion for you, so your documents are ready to use in TraceX with minimal manual effort on your part. Let us take care of the tedious tasks, allowing you to focus on what matters most - your compliance goals.
Are there document templates available to help set up our QMS (e.g., work instructions, procedures)?
While TraceX itself does not provide QMS templates directly, you can access them through our network of expert partners. These partners offer ready-to-use templates for Work Instructions, Procedures, Forms, and more, all tailored to meet ISO 13485, FDA 21 CFR Part 11, and EU MDR requirements.
Our Regulatory Expert Partners can help you implement and customize these templates to fit your company’s specific processes and ensure your QMS is audit-ready.
To find the right partner who can provide the templates and support you need, simply go to Find a partner. Do you also provide consultancy to set up a QMS?
TraceX itself does not provide direct consultancy services, but we’ve built a network of trusted Quality & Regulatory experts who can help you with QMS setup and implementation.
Through the TraceX Partner Network, you can connect with experienced consultants who specialize in setting up Quality Management Systems that meet regulatory requirements such as ISO 13485, 21 CFR Part 11, and EU MDR. These partners can assist with everything from initial setup to system validation, technical documentation, and ongoing compliance support.
Simply use our “Find a Partner” tool to search for the expertise you need and get tailored support from a qualified QARA consultant.
How can we validate TraceX?
We understand that system validation is a critical part of compliance, especially for companies operating in regulated industries. If you do not have the internal resources, you can access validation services through our network of expert partners.
Our Regulatory Expert Partners can provide ready-to-use validation packages, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols, tailored to the TraceX platform. They can also assist with custom validation processes to ensure your eQMS meets the requirements of ISO 13485, FDA 21 CFR Part 11, and other relevant standards.
These partners help you save time and reduce effort by guiding you through the validation process, providing documentation, and ensuring your eQMS is fully validated and audit-ready.
To connect with a partner offering validation services, go to Find a partner. Is there any user guide?
Yes! We provide a comprehensive user guide to help you get started with TraceX and make the most of the platform’s features. You can access the guide here:👉
User GuideIn addition to the user guide, we offer demo sessions and tutorial videos on our YouTube channel to walk you through key functionalities, from setting up your QMS to managing product lifecycles.👉
Visit Our YouTube ChannelThese resources are designed to make your onboarding experience smooth and to ensure your team is fully equipped to use TraceX efficiently. I can read that TraceX is built on top of the Huly platform. What does that mean?
TraceX is specifically designed to simplify compliance and operations for regulated industries. It is built on top of Huly, a process, project, time, and knowledge management platform that provides advanced collaboration tools.
With Huly, users can:
✅ Manage processes, projects, and knowledge
✅ Collaborate in real-time with high-quality audio and video conferencing
✅ Create customized virtual office spaces for companies.
By building on Huly, TraceX inherits these collaboration and management features, allowing regulated companies to benefit from tools like chat, task management, and virtual meetings while focusing on their compliance needs.For more information about Huly, visit Huly.io or check out Huly YouTube channel for demos and tutorials. Where is the cloud solution hosted?
TraceX offers cloud hosting in both the US and EU, allowing users to select their workspace’s region to meet regulatory requirements and optimize performance.
For regulatory purposes, data hosted in strict regulatory regions (US or EU) remains within those borders to comply with local laws.
In contrast, performance-based regions - such as western and eastern EU, Asia, and various US regions - are optimized to improve speed and responsiveness. However, data stored in these regions may still move between servers across locations, depending on load balancing and network optimization. If your priority is data residency compliance, choosing a strict regulatory region guarantees that your data stays within the selected jurisdiction.
What is TraceX’s backup policy?
TraceX ensures data security and availability through a multi-layer backup system, combining automated system-level backups and user-initiated backups.
1. Hosting Provider Backup (Cloudflare)
TraceX leverages Cloudflare’s secure infrastructure, which includes provider-level backups to protect your data.
2. System-Level Backups
• Full Backups: Automatically performed every 12 hours and stored for up to 7 days.
• Incremental Backups: Continuously running to capture real-time changes and minimize data loss.
The restoration process involves using the latest full backup, followed by applying incremental backups to recover the most recent data.
3. User-Initiated Backups
• PDF Export: Users can export documents as PDFs to preserve records in a readable format.
• Manual Full Backups: Users can perform full backups from the desktop app (coming soon to the web app). These backups are provided in open data formats, allowing users to retrieve and use their data outside of TraceX, in case they need to migrate or integrate it with other tools.
SummaryTraceX offers secure, automated backups and user-driven options, with open data formats to ensure your data is always protected, accessible, and recoverable across different systems.
What is the cybersecurity protection?
Protecting sensitive information like customer IPs is a top priority for us, so let us clarify for you.
We utilize Cloudflare.com R2 for object storage, which ensures data is encrypted both at rest and in transit, and complies with standards like ISO 27001 and SOC 2 Type II.
Additionally, we integrate it with other Cloudflare services, such as:
- DDoS Protection to safeguard against large-scale attacks.
- Web Application Firewall (WAF) to block threats like SQL injections and XSS.
- Bot Management to prevent unauthorized access by malicious bots.
- Access Controls to restrict and monitor access securely.
To provide even greater security, we can explore custom solutions tailored to your needs. For example, we could set up a secure VPN connection from your office or specific IPs to your TraceX instance, ensuring no external access is possible.
There are many additional possibilities, and we would be happy to discuss your specific requirements further.
Is data encrypted with TraceX?
Strictly speaking, not currently (like many other SaaS & eQMS tools, as they may have back-end access to your data). Of course traffic to servers is encrypted with HTTPS, but your data is still accessible to admins (either self-hosted or cloud version).
However, we're planning next-generation TraceX where everything will be E2E encrypted with military grade encryption, such as AES, ChaCha20, and use public key cryptography such as ECDSA. Moreover it will be blockchain based and totally secured. We plan to rollout it in two stages - the first fully encrypted solution will go to the domain, and to blockchain later. Even if the blockchain part fails, the domain will be fully encrypted anyway.
We do not have a technical whitepaper on TraceX Blockchain yet, but have some org governance documents already. Is it possible to self host our data?
Yes, we support both self-hosted and SaaS methods for TraceX, you can choose the option that best suits your needs.
Self-hosted: You host and manage the software on your own servers. Find here the instructions for self-hosting.
SaaS: The software is hosted and managed by TraceX and hosting provider. Does TraceX integrate with 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.
Does TraceX offer an API?
Yes we do! You can find more information and examples here. Please feel free to share any feedback you might have as you explore the API. 
