Top 10 Best Quality Management Systems Software of 2026

MasterControl is a comprehensive Quality Management Systems (QMS) software platform tailored for regulated industries like life sciences, medical devices, and manufacturing. It streamlines critical processes including document control, CAPA, audits, training, complaints, and supplier management to ensure compliance with FDA 21 CFR Part 11, ISO 13485, and GMP standards. The cloud-based or on-premise solution offers robust automation, real-time analytics, and integrations to enhance operational efficiency and reduce compliance risks.

ETQ Reliance is a cloud-based Quality Management System (QMS) software that provides end-to-end solutions for managing quality processes including audits, CAPA, complaints, supplier management, document control, and risk assessments. It emphasizes configurability, enabling organizations to tailor workflows to specific needs without coding, while ensuring compliance with standards like ISO 9001, FDA, and IATF 16949. The platform leverages AI-driven insights and automation to drive continuous improvement and operational excellence in regulated industries.

Qualio is a cloud-based eQMS platform designed for life sciences companies, streamlining quality management processes like document control, training, CAPA, non-conformances, audits, and supplier management. It ensures compliance with FDA 21 CFR Part 11, ISO 13485, and EU MDR through electronic signatures, audit trails, and configurable workflows. Qualio stands out for its modern interface and rapid deployment, enabling teams to go live in weeks without extensive IT support.

ComplianceQuest is a cloud-based Quality Management System (QMS) software built natively on the Salesforce platform, offering end-to-end solutions for quality processes like CAPA, complaints handling, audits, document control, supplier management, and non-conformance. It supports compliance with standards such as ISO 9001, FDA 21 CFR Part 11, IATF 16949, and others, particularly in regulated industries like life sciences, automotive, and manufacturing. The platform leverages Salesforce's scalability and security for seamless integration with CRM data, providing a unified view of customer quality interactions.

Intellect is a cloud-based Quality Management System (QMS) platform that provides configurable tools for managing quality processes such as CAPA, audits, document control, complaints, training, and supplier management. It supports compliance with standards like ISO 9001, FDA 21 CFR Part 11, and SOX through automated workflows and real-time reporting. Designed for regulated industries, it allows no-code customization to fit specific organizational needs without requiring IT development.

AssurX is a robust enterprise Quality Management System (QMS) software designed primarily for highly regulated industries like insurance, banking, healthcare, and manufacturing. It excels in managing quality events such as complaints, incidents, and non-conformances, while supporting CAPA processes, audits, risk management, document control, and employee training. The platform's configurable workflows and automation help organizations maintain compliance with standards like ISO 9001, FDA regulations, and SOX.

Ideagen Quality Management is a robust enterprise-grade Quality Management System (QMS) software suite designed to help organizations achieve and maintain compliance with standards like ISO 9001, ISO 14001, and FDA regulations. It provides tools for document control, audit management, CAPA processes, non-conformance tracking, risk assessment, and supplier management to drive continuous improvement and operational efficiency. The platform emphasizes integrated governance, risk, and compliance (GRC) capabilities, making it suitable for complex, regulated environments.

Qualityze is a cloud-based Enterprise Quality Management System (eQMS) designed for regulated industries like life sciences, manufacturing, and automotive. It offers modular solutions for CAPA, audits, document control, training management, complaints, nonconformance, supplier quality, and risk management, ensuring compliance with FDA 21 CFR Part 11, ISO 13485, and other standards. The platform emphasizes configurable workflows, real-time analytics, and mobile access to drive digital quality transformation and operational efficiency.

Greenlight Guru is a cloud-based electronic Quality Management System (eQMS) software purpose-built for the medical device industry, automating key processes like document control, CAPA, risk management, audits, and change control. It ensures compliance with FDA 21 CFR Part 820/11 and ISO 13485 standards through pre-configured templates and workflows tailored to medtech lifecycles. The platform integrates quality events, training, and supplier management to streamline operations from design to commercialization.

TrackWise by Honeywell is an enterprise-grade Quality Management System (QMS) software tailored for highly regulated industries such as pharmaceuticals, biotechnology, and medical devices. It provides end-to-end management of quality processes including CAPA, complaints, audits, deviations, supplier quality, and training. The platform emphasizes compliance with standards like FDA 21 CFR Part 11, GxP, and ISO, offering configurable workflows, robust analytics, and integration capabilities for seamless operations.