TraceX offers an all‑in‑one electronic quality management system and product lifecycle management platform for medtech and pharma companies, enabling teams to manage document versions, audit trails, risk assessments, and design control while staying audit‑ready for CE, FDA, ISO, and GxP standards.
Funding
Funding not disclosed
Founders
Product
Problem
Medtech and pharmaceutical companies often rely on fragmented tools and paper-based processes to manage quality documentation, design control, risk assessments, and regulatory compliance, leading to version control errors, audit delays, and inefficient collaboration.
Solution
TraceX provides a unified electronic quality management system (eQMS) and product lifecycle management (PLM) platform that centralizes document control, approval workflows, electronic signatures, and training records. The solution tracks product development from concept through post‑market surveillance, embedding risk management and ISO/CE/FDA compliance checks into each stage. Built‑in collaboration tools eliminate the need for separate communication apps, keeping teams aligned within a single interface. Customizable modules and a powerful module builder allow organizations to tailor processes to their specific regulatory frameworks. Cloud‑based access via web browser or desktop app ensures audit readiness at any time, while electronic signatures meet 21 CFR Part 11 requirements.
Target Audience
Primary customers are medtech and pharmaceutical manufacturers, as well as regulatory consultants who need an integrated, audit‑ready solution for quality and product development management.
Features
- Versioned document repository with immutable audit trails and configurable approval workflows
- Electronic signatures compliant with FDA 21 CFR Part 11 and other GxP standards
- Integrated risk management aligned with ISO 14971, including CAPA and non‑conformance tracking
- Full PLM capabilities: requirement management, design control, verification/validation, and traceability matrix
- Test and change management modules with automated traceability across the product lifecycle
- Built‑in virtual office, chat, wiki, and file drive for seamless team collaboration
- Modular architecture allowing creation of custom eQMS or PLM components without code
- Web and desktop access with role‑based permissions for consultants, read‑only users, and community members