Top 10 Best Qms Systems Software of 2026

MasterControl is a comprehensive, cloud-based Quality Management System (QMS) software designed for regulated industries such as life sciences, manufacturing, and medical devices. It automates critical processes including document control, CAPA, audit management, training, complaints handling, and supplier management to ensure compliance with FDA 21 CFR Part 11, ISO 13485, and other standards. The platform provides end-to-end visibility and connectivity across quality operations, reducing manual errors and accelerating time-to-market.

ETQ Reliance is a cloud-based Quality Management System (QMS) software designed to automate and streamline core quality processes such as audits, CAPA, complaints, supplier management, and document control. It excels in regulated industries like life sciences, manufacturing, and automotive by providing configurable workflows without coding, ensuring compliance with standards like ISO 9001, FDA 21 CFR Part 11, and IATF 16949. The platform's Active Intelligence layer delivers real-time analytics and predictive insights to proactively manage quality risks.

Qualio is a cloud-based electronic Quality Management System (eQMS) tailored for life sciences companies, including biotech, pharma, and medtech firms. It centralizes document control, training management, CAPA, change control, audits, and supplier quality in a compliant platform supporting FDA 21 CFR Part 11, ISO 13485, and EU MDR. The software emphasizes automation, collaboration, and scalability to accelerate validation, reduce paper-based processes, and improve audit readiness.

ComplianceQuest is a cloud-based Enterprise Quality Management System (EQMS) built natively on the Salesforce platform, offering a comprehensive suite of tools for managing quality processes. It covers key QMS functionalities including CAPA, audits, document control, non-conformances, complaints, supplier quality, training, and risk management. The software excels in regulated industries by ensuring compliance with standards like ISO 9001, ISO 13485, FDA 21 CFR Part 11, and IATF 16949 through configurable workflows and robust reporting.

Veeva QualityOne is a cloud-native Quality Management System (QMS) tailored for life sciences organizations, enabling streamlined management of quality processes like audits, CAPA, complaints, training, and supplier quality. It integrates seamlessly with Veeva Vault for unified document control and compliance, supporting FDA, EMA, and other regulatory requirements. The platform leverages AI-driven insights for proactive quality improvements and real-time analytics to enhance decision-making.

AssurX is a robust enterprise Quality Management System (QMS) software tailored for regulated industries like insurance, manufacturing, life sciences, and financial services. It provides configurable modules for CAPA, audits, complaints, document control, risk management, and supplier quality, ensuring compliance with standards such as ISO 9001, FDA 21 CFR Part 11, and SOX. The platform excels in streamlining complex workflows and integrating with ERP and other enterprise systems to drive operational excellence and risk mitigation.

Greenlight Guru is a cloud-based electronic Quality Management System (eQMS) platform purpose-built for medical device companies, helping them achieve and maintain compliance with FDA 21 CFR Part 820, ISO 13485, and other medtech regulations. It provides integrated modules for design controls, risk management (including FMEA), CAPA, document control, audits, training, and complaints, automating workflows to streamline quality processes from R&D to post-market surveillance. The software emphasizes collaboration, traceability, and real-time reporting to reduce compliance risks and accelerate time-to-market.

QT9 QMS is a cloud-based Quality Management System software tailored for manufacturing and regulated industries, offering modular tools for document control, CAPA, audits, training, supplier management, nonconformances, and calibration. It ensures compliance with standards like ISO 9001, AS9100, and FDA requirements through automated workflows and real-time dashboards. The platform stands out for its quick implementation and scalability without per-user licensing fees.

Ideagen Quality Management is a comprehensive suite of EHSQ (Environment, Health, Safety, and Quality) software solutions designed to streamline compliance, audit, risk management, and quality processes for regulated industries. It includes modules for document control, incident reporting, corrective and preventive actions (CAPA), supplier management, and real-time analytics. The platform emphasizes mobile accessibility and integration with enterprise systems to support ISO standards and regulatory requirements like FDA, ISO 9001, and OSHA.

Intellect QMS is a cloud-based, no-code quality management system designed for regulated industries such as pharmaceuticals, medical devices, and manufacturing. It provides comprehensive modules for CAPA, audits, document control, complaints, training, supplier management, and risk assessment to ensure compliance with standards like ISO 9001, FDA 21 CFR Part 11, and GMP. The platform emphasizes intelligent workflows and configurability to streamline quality processes and drive continuous improvement.