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.
Is TraceX limited to specific regulations, standards, or regions?
No — TraceX is fully agnostic.
The platform is designed to support any regulatory framework, localization, or industry standard. Whether you’re working under EU MDR, FDA, ISO 13485, GxP, or other national or international requirements, TraceX can be fully adapted to your needs.
TraceX gives you a flexible foundation to support any product, market, or process, regardless of industry or location.
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 TraceX short video These resources are designed to make your onboarding experience smooth and to ensure your team is fully equipped to use TraceX efficiently. Where is the data hosted?
All data is securely hosted with Hetzner in Germany, ensuring compliance with European data protection and privacy regulations (GDPR) and with ISO/IEC 27001:2022 certification, ensuring industry-standard information security.
What is TraceX backup policy?
TraceX ensures data security and availability through a multi-layer backup system, combining automated system-level backups and user-initiated backups.
1. System-level backups
• Incremental backups: Automatically performed every 12 hours
2. User-Initiated backups
• PDF export: Users can export documents as PDFs to preserve records in a readable format.
• Auto Snapshot backups on the web app: Users can retrieve auto-generated full backups via the web app.
What is TraceX restoration process?
All operations in TraceX, whether performed by users or the system, are executed as transactions, similar to database transactions. There is no concept of files in TraceX; instead, everything is stored as either database records or binary blobs.
• Fast snapshot recovery: Database records and blobs are restored from snapshots.
• Incremental backup restoration: A complete log of all transactions is maintained from the moment a workspace is created. To restore a workspace to a specific point in time, all relevant transactions are retrieved from the backup and applied accordingly.
Exceptions exist for large files (e.g., multi-gigabyte video files), which are not included in the transaction log. Instead, they require a snapshot for recovery.
What is the cybersecurity protection?
Protecting sensitive information like customer IPs is a top priority for us, so let us clarify for you.
Our data is securely hosted with Hetzner in Germany, inside ISO 27001–certified facilities. All information is encrypted both at rest and in transit, and hosting in Germany ensures full GDPR compliance.
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. 
