Pre-Validated QMS. Local European Support. 

Yes. QT9 QMS provides tools that support ISO 9001 requirements, including document control, corrective actions, internal audits, employee training and risk management. The software helps organisations streamline compliance activities and maintain records required for certification audits. 

Yes. QT9 QMS helps medical device manufacturers and suppliers manage quality processes aligned with ISO 13485 requirements. The platform centralises documentation, training records, supplier quality management, CAPA and audit preparation within a single system. 

Yes. Many European medical device and pharmaceutical manufacturers export to the United States and must comply with both EU MDR and FDA quality requirements simultaneously. QT9 QMS supports FDA 21 CFR Part 11 compliant electronic signatures, FDA QMSR and cGMP workflows — allowing European manufacturers to manage EU and US compliance requirements within a single platform. QT9 Europe's team in Killarney has experience supporting organisations operating across both regulatory environments. 

QT9 QMS is available as both a cloud-based and on-premise solution. European customers benefit from our dedicated EU data centre in Amsterdam for cloud deployments, while on-premise options are available for organisations with specific data residency or infrastructure requirements.

Yes. QT9 QMS centralises audit records, training documentation, CAPA activities and controlled documents, making it easier to prepare for internal, customer and certification audits. Automated workflows help organisations maintain audit readiness throughout the year. 

QT9 QMS provides document version control, approval workflows, revision histories, automated notifications and secure access permissions. This helps ensure employees always work from the latest approved documents while maintaining complete traceability. 

Yes. QT9 QMS is designed to support multi-site organisations by providing standardised quality processes, centralised data management and real-time visibility across facilities. This helps maintain consistency and compliance throughout the organisation.

These eight target the highest-value search intents:

• QMS software Ireland
• ISO 9001 software
• ISO 13485 software
• FDA compliance software
• Cloud QMS
• Audit management software
• Document control software
• Multi-site quality management system

They also align closely with what prospective buyers typically ask before booking a demo.

QT9 is delivered with validation documentation to support regulated organizations. Subscribers receive a comprehensive validation report, helping streamline software validation activities and reduce implementation effort. 

Yes. QT9 electronic signatures support compliance with FDA 21 CFR Part 11 and EU GMP Annex 11 requirements, helping organizations maintain secure, traceable, and compliant electronic records and approvals. 

QT9 supports organizations throughout Ireland, the UK, Europe, North America, the Middle East, and other global markets. The platform is designed for single-site operations as well as multinational organizations requiring standardized quality processes across multiple locations.