Top 10 Best Enterprise Quality Management Software of 2026

ETQ Reliance is a cloud-based Enterprise Quality Management System (EQMS) designed for large organizations to streamline quality processes across the enterprise. It offers end-to-end capabilities including document control, audits, CAPA, non-conformance management, supplier quality, complaints handling, and risk management, all within a highly configurable no-code platform. The software emphasizes compliance in regulated industries like life sciences, automotive, and manufacturing, with AI-driven insights for predictive analytics and continuous improvement.

MasterControl is a comprehensive Enterprise Quality Management System (eQMS) tailored for regulated industries like life sciences, manufacturing, and medical devices. It offers end-to-end solutions for document control, CAPA, audit management, training, complaints, and supplier quality to ensure compliance with FDA 21 CFR Part 11, ISO 13485, and other standards. The platform automates quality processes, reduces manual errors, and provides real-time visibility to accelerate product releases and minimize risks.

Veeva QualityOne is a cloud-native Enterprise Quality Management System (EQMS) tailored for regulated industries like life sciences, pharmaceuticals, biotech, and medical devices. It unifies core quality processes including quality events, audits, CAPA, complaints, training, and supplier management within a single platform built on the Veeva Vault infrastructure. The solution emphasizes compliance with standards such as FDA 21 CFR Part 11, EU Annex 11, and ISO 13485, while offering configurable workflows, real-time analytics, and seamless integration with other Veeva applications for end-to-end quality control.

IQVIA SmartSolve is a robust enterprise quality management system (eQMS) tailored for life sciences industries, including pharma, biotech, and medical devices. It manages critical processes like CAPA, audits, complaints, training, document control, and supplier quality with built-in compliance for FDA 21 CFR Part 11, EU Annex 11, and ISO standards. The platform provides configurable workflows, real-time dashboards, and analytics to drive proactive quality improvements and risk mitigation.

AssurX is a comprehensive enterprise quality management system (QMS) designed specifically for highly regulated industries such as life sciences, medical devices, and manufacturing. It unifies key processes including complaints management, CAPA, audits, training, supplier quality, risk management, and adverse event reporting into a single configurable platform. The software ensures compliance with stringent regulations like FDA 21 CFR Part 11, ISO 13485, and GxP through robust audit trails, electronic signatures, and validation-ready features. Its no-code configuration capabilities allow organizations to tailor workflows to their specific needs without extensive development.

ComplianceQuest is a cloud-based Enterprise Quality Management System (EQMS) built natively on the Salesforce platform, providing end-to-end solutions for quality compliance, CAPA, audits, nonconformance, complaints, supplier management, and training. It enables organizations to digitize and automate quality processes while ensuring regulatory adherence to standards like ISO 9001, FDA 21 CFR Part 11, and IATF 16949. Leveraging Salesforce's scalability, it offers seamless integration with CRM, ERP, and other enterprise systems for a unified data ecosystem.

Qualio is a cloud-native electronic Quality Management System (eQMS) tailored for life sciences companies, including biotech, pharma, and medical device firms. It centralizes document control, training, CAPA, supplier management, audits, complaints, and change control in a compliant platform supporting FDA 21 CFR Part 11, ISO 13485, and EU Annex 11. The software emphasizes automation, collaboration, and scalability to streamline quality operations and accelerate product development.

Greenlight Guru is a cloud-based electronic Quality Management System (eQMS) platform purpose-built for the medical device industry. It streamlines compliance with FDA 21 CFR Part 820, ISO 13485, and other regulations through integrated tools for document control, risk management, CAPA, change control, audits, and training. The software accelerates product development by linking quality processes directly to design controls, reducing manual work and audit risks.

Ideagen Quality Management is a comprehensive enterprise software suite focused on EHSQ (Environment, Health, Safety, and Quality) processes, offering tools for document control, audit management, CAPA, non-conformance tracking, supplier management, and risk assessment. It supports compliance with standards like ISO 9001, ISO 14001, FDA 21 CFR Part 11, and others, enabling centralized management of quality workflows across global operations. The modular platform integrates seamlessly for holistic regulatory adherence in regulated industries.

Hexagon Pilgrim is a robust Enterprise Quality Management System (EQMS) tailored for regulated industries like life sciences, pharmaceuticals, and manufacturing. It centralizes quality processes such as CAPA, audits, complaints, nonconformances, training, document control, and supplier management within a configurable platform. The software ensures compliance with standards including FDA 21 CFR Part 11, ISO 13485, and GxP through validated workflows, electronic signatures, and advanced reporting.