QMS

QT9 QMS by QT9 Software is an all-in-one, pre-validated electronic quality management system designed for regulated industries including medical devices, pharmaceuticals, life sciences, aerospace, automotive, food and beverage, and general manufacturing. The platform centralises more than 25 integrated QMS modules on a single, scalable system, enabling organisations to automate compliance efforts, maintain audit readiness, and streamline quality processes across the entire product lifecycle. With implementation achievable in as little as 30 days, QT9 QMS is trusted by over 1,200 companies worldwide.

QT9 QMS is available as a cloud-hosted or on-premise solution, with infrastructure hosted in both the US and Europe to support GDPR-compliant data residency requirements. The platform uses concurrent licensing with no per-user fees, includes unlimited portal access for customers, suppliers, and employees, and provides unlimited file storage and training resources at no additional cost — making it a cost-effective alternative to traditional QMS software.

Core Modules and Capabilities

• Document control with centralised storage, revision tracking, and parallel document collaboration for simultaneous editing
• CAPA and non-conformance management with real-time tracking and automated workflows
• Audit management and scheduling, including a dedicated Audit Prep module for instantly viewing overdue or missing records
• Training management with online personalised tests, certification tracking, and the ability to create training records directly from Corrective Actions or Quality Events
• Risk management with risk scoring, task assignment, prioritisation, and electronic approvals
• Supplier quality management and supplier web portals
• Customer feedback tracking and complaint management
• Engineering change control (ECR/ECN) with task assignment, email alerts, and electronic approvals
• Deviation monitoring with email alerts and to-do lists
• Inspection management with online capture and linked document references
• Incident report generation directly from Quality Events
• Product design controls and device history records (DHR/MDR/MDF) and batch records (MBR/EBR) automation
• Dynamic reporting for full traceability and real-time visibility across quality processes

Pre-Validation and Compliance

• QT9 QMS ships pre-validated with completed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, eliminating costly internal validation efforts
• Supports a broad range of global regulatory standards including ISO 13485, ISO 9001, ISO 14001, ISO 17025, AS9100, IATF 16949, FDA 21 CFR Parts 11, 210, 211, and 820, EU MDR, EU GMP, GxP, HACCP, SQF, and MoCRA
• Built-in electronic signatures and automatic audit trails for FDA 21 CFR Part 11 compliance
• Continuous validation and updates ensure ongoing compliance without additional internal investment
• Audit-ready timeline traceability enables transparency into every action, supporting defect identification and targeted batch recalls

Automation and Workflow Features

• Next-generation embedded automation workflows reduce manual checks and accelerate decision-making
• Automated alerts and notifications keep teams informed of quality events and required actions
• Dynamically populated data and automated approvals shorten time-to-market and reduce data-entry errors
• Real-time quality data access supports faster, smarter decisions across distributed teams
• Single Sign-On (SSO) portals enable secure access to document and employee portals

Portals and Collaboration

• Dedicated web portals for employees, customers, and suppliers provide secure access to vital documents
• Portals improve cross-organisational communication and collaboration without additional licensing fees
• Multi-site support is included as standard

Learning and Support

• QT9 University provides on-demand online training resources and a community forum for continuous learning
• Unlimited training and support are included with no annual training fees
• User-friendly interface designed to minimise the learning curve for teams of all sizes, from start-ups to enterprises

QT9 QMS integrates natively with QT9 ERP, enabling seamless data flow between quality and operations. The platform is recognised as a leader in quality management software on G2, Capterra, Software Advice, and GetApp, and is designed to help organisations reduce compliance risk, improve audit outcomes, and drive continuous quality improvement.