Top 10 Best Qualitätsmanagement Software of 2026

MasterControl is a comprehensive quality management system (QMS) software designed for regulated industries, providing an integrated platform to automate and streamline processes like document control, CAPA, audits, training, complaints, and supplier management. It ensures compliance with standards such as FDA 21 CFR Part 11, ISO 13485, and GxP requirements through validated electronic signatures and audit trails. The cloud-based or on-premise solution connects quality data across the organization to drive continuous improvement and risk reduction.

ETQ Reliance is a comprehensive Quality Management System (QMS) software platform designed for enterprises to manage end-to-end quality processes including CAPA, audits, complaints, document control, supplier management, and non-conformances. It excels in regulated industries like manufacturing, life sciences, and automotive by providing configurable workflows that automate compliance and drive continuous improvement. The cloud-based or on-premise solution integrates seamlessly with ERP and other enterprise systems for holistic quality oversight.

Qualio is a cloud-based electronic Quality Management System (eQMS) tailored for life sciences companies, streamlining quality processes like document control, CAPA, training, audits, complaints, and supplier management. It ensures regulatory compliance with FDA 21 CFR Part 11, ISO 13485, and EU MDR through automated workflows, electronic signatures, and full audit trails. The platform emphasizes configurability without coding, enabling rapid deployment and scalability for growing organizations.

ComplianceQuest is a cloud-based Enterprise Quality Management System (EQMS) built natively on the Salesforce platform, enabling organizations to streamline quality processes like CAPA, audits, complaints, nonconformance, document control, and supplier management. It supports compliance with standards such as ISO 9001, ISO 13485, and FDA 21 CFR Part 11, while integrating quality data with CRM for a unified view. The platform offers no-code customization, AI-driven insights, and robust reporting to drive continuous improvement in regulated industries.

Veeva QualityOne is a cloud-based quality management system (QMS) tailored for the life sciences industry, including pharmaceuticals, biotech, and medical devices. It automates and streamlines core quality processes such as audits, CAPA, complaints handling, training management, supplier quality, and document control. Built on the Salesforce platform, it ensures regulatory compliance (e.g., FDA, EMA) with real-time collaboration, mobile access, and AI-driven insights for proactive quality management.

Greenlight Guru is a cloud-based electronic Quality Management System (eQMS) tailored specifically for medical device companies to manage quality processes in compliance with regulations like FDA 21 CFR Part 820 and ISO 13485. It provides integrated tools for document control, risk management (including FMEA), CAPA, audits, training management, and design controls, enabling teams to maintain traceability and audit readiness. The platform emphasizes collaboration and automation to accelerate product development while reducing compliance risks.

AssurX is an enterprise-grade Quality Management System (QMS) tailored for highly regulated industries like insurance, healthcare, life sciences, and manufacturing. It offers modules for complaints management, CAPA, audits, document control, training, supplier management, and risk assessment, with strong emphasis on compliance standards such as FDA 21 CFR Part 11, ISO 9001, and SOX. The platform enables configurable workflows, real-time analytics, and automation to streamline quality processes and ensure audit readiness.

Intellect QMS is a cloud-based quality management system platform tailored for regulated industries like pharmaceuticals, medical devices, and manufacturing. It provides configurable modules for CAPA, audits, complaints handling, document control, supplier management, nonconformance, and training to ensure compliance with standards such as ISO 9001, FDA 21 CFR Part 11, and ISO 13485. The no-code/low-code interface allows users to customize workflows, forms, and reports without programming expertise.

QT9 QMS is a cloud-based quality management software tailored for manufacturers, providing an all-in-one platform for document control, CAPA, audits, non-conformances, supplier management, training, calibration, and customer complaints. It ensures compliance with standards like ISO 9001, AS9100, IATF 16949, and FDA regulations through automated workflows and real-time dashboards. The system scales effortlessly with unlimited users, storage, and support included in its pricing model.

Unipoint is a cloud-based quality management software tailored for manufacturing and regulated industries, offering modules for CAPA, audits, complaints, non-conformances, document control, training, and supplier management. It supports compliance with ISO 9001, ISO 13485, and FDA requirements through automated workflows and real-time reporting. The platform emphasizes visual process mapping and integration with ERP systems like SAP and Oracle.