TraxQM is a modern cloud-based electronic Quality Management System (eQMS) designed specifically for pharmaceutical wholesalers, manufacturers, distributors, and regulated healthcare organisations. This comprehensive platform enables quality and compliance teams to efficiently manage critical processes such as document control, training, quality events, risk management, audits, supplier evaluations, and approvals—all within a single validated environment. TraxQM is aligned with stringent regulatory standards, including EU GMP Annex 11, GDP, 21 CFR Part 11, and GAMP 5 expectations, effectively eliminating the need for spreadsheets, manual approvals, and disparate systems.
The platform’s core feature is the unified Event Manager, which centralises the management of various quality events, including deviations, CAPA (Corrective and Preventive Actions), complaints, change controls, recalls, and returns. Configurable workflows guide users through each event's lifecycle, ensuring consistent handling and regulatory traceability. By linking quality events directly to products, batches, suppliers, and risk assessments, organisations can swiftly identify systemic issues and prevent recurrence. Automated task assignments, reminders, and real-time dashboards enhance team efficiency, ensuring that quality events are resolved promptly while maintaining continuous inspection readiness.
TraxQM also excels in document management, offering full lifecycle control that includes automated workflows for document creation, review, approval, and versioning. The platform supports electronic signatures compliant with 21 CFR Part 11 and Annex 11, along with comprehensive audit trails and automated review reminders. This functionality ensures that controlled documents remain secure, compliant, and ready for inspection at all times, thereby streamlining quality assurance processes.
In addition to document management, TraxQM features integrated training management capabilities. With role-based training matrices, competency assessments, and certification tracking, organisations can ensure that personnel remain qualified and compliant with GMP and Annex 11 requirements. This functionality provides real-time visibility into training status, allowing organisations to proactively manage workforce compliance.
The platform's risk management and audit functionalities promote a proactive, risk-based approach to quality oversight. Configurable risk registers aligned with ICH Q9 and FMEA methodologies enable organisations to identify and assess risks effectively, linking them directly to quality events and suppliers. Risk-based audit scheduling prioritises audits based on supplier criticality and performance history, ensuring that resources are focused where they are needed most.
TraxQM distinguishes itself from traditional eQMS platforms by offering dedicated mobile applications for iOS and Android. This feature allows users to manage tasks, complete approvals, and respond to quality events from virtually anywhere. Real-time push notifications and optional OTP-secured approvals enhance regulatory compliance while maintaining secure and compliant remote quality management.
With AI-powered compliance assistance trained on UK MHRA and EU GMP and GDP guidelines, TraxQM helps quality teams review documents, assess risks, and identify compliance gaps more efficiently. The platform is hosted on secure AWS infrastructure within the EU region, providing enterprise-grade security measures such as role-based access control and encryption. Organisations utilising TraxQM benefit from faster deployment, improved audit readiness, and a scalable solution designed to support regulatory compliance and operational growth.
Average Rating: 4.5/5.0
Total Reviews: 2
How Do G2 Users Rate TraxQM?
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Has the product been a good partner in doing business?: 10.0/10 (Category avg: 9.2/10)
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Quality Processes: 10.0/10 (Category avg: 9.0/10)
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Audit Management: 10.0/10 (Category avg: 8.7/10)
Who Is the Company Behind TraxQM?
