Top 10 Best Quality System Management Software of 2026

MasterControl is a leading enterprise Quality Management System (QMS) software platform tailored for highly regulated industries such as life sciences, manufacturing, and medical devices. It offers end-to-end solutions for document control, CAPA management, audit tracking, training, complaints, supplier management, and non-conformance handling, ensuring compliance with FDA 21 CFR Part 11, ISO 13485, and other global standards. The platform automates quality processes, accelerates approvals, and provides real-time analytics to minimize risks and enhance operational efficiency.

ETQ Reliance is a robust, cloud-based Quality Management System (QMS) software that centralizes and automates core quality processes such as audits, CAPA, complaints, document control, supplier management, and training. It excels in regulated industries by providing configurable workflows, real-time analytics, and compliance tools aligned with standards like ISO 9001, FDA 21 CFR Part 11, and IATF 16949. The platform's no-code environment enables rapid customization to fit unique business needs without extensive programming.

Qualio is a cloud-based electronic Quality Management System (eQMS) designed specifically for life sciences companies, including biotech, pharma, and medtech firms. It centralizes document control, training management, quality events (such as CAPA, non-conformances, and complaints), supplier management, and audit tracking to ensure regulatory compliance with standards like FDA 21 CFR Part 11, ISO 13485, and EU MDR. The platform emphasizes speed, simplicity, and scalability, enabling rapid deployment and ongoing quality operations without heavy IT involvement.

ComplianceQuest is a robust Quality Management System (QMS) software built natively on the Salesforce platform, enabling organizations to manage compliance, quality processes, and risk in regulated industries like life sciences, manufacturing, and automotive. It provides end-to-end modules including CAPA, audits, complaints handling, document control, supplier quality, training management, and nonconformance, all while ensuring adherence to standards such as ISO 9001, FDA 21 CFR Part 11, and IATF 16949. The platform excels in customization and scalability, leveraging Salesforce's no-code tools for tailored workflows and seamless CRM integration.

Greenlight Guru is a cloud-based electronic Quality Management System (eQMS) platform purpose-built for medical device companies. It centralizes key quality processes including document control, risk management (per ISO 14971), CAPA, audits, training, and design controls to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other medtech regulations. The software offers pre-configured templates, automated workflows, and reporting tools to streamline operations and accelerate time-to-market while reducing compliance risks.

Veeva QualityOne is a cloud-based Quality Management System (QMS) tailored for the life sciences industry, enabling streamlined management of quality processes like CAPA, audits, complaints, training, inspections, and supplier quality. Built on the Veeva Vault platform, it ensures compliance with stringent regulations such as FDA 21 CFR Part 11, EU Annex 11, and ISO standards through validated, configurable workflows and real-time analytics. The solution supports mobile access and AI-driven insights to improve risk management and operational efficiency across global enterprises.

AssurX is an enterprise-grade Quality Management System (QMS) tailored for highly regulated industries like pharmaceuticals, medical devices, biotechnology, and manufacturing. It offers a unified platform with modules for complaint management, CAPA, audit tracking, training, document control, supplier management, and risk assessment, ensuring compliance with FDA 21 CFR Part 11, ISO 13485, and other standards. The software emphasizes configurable workflows, automation, and real-time reporting to drive continuous improvement and operational efficiency.

Intelex is a robust cloud-based EHSQ (Environment, Health, Safety, and Quality) management platform that provides comprehensive tools for quality system management, including audits, CAPA, non-conformance tracking, document control, and supplier management. It enables organizations to standardize quality processes, ensure compliance with standards like ISO 9001, and drive continuous improvement through data-driven insights. The platform's low-code configurability allows users to tailor workflows without extensive IT support.

Intellect is a cloud-based Quality Management System (QMS) software designed to streamline quality processes for regulated industries, offering modules for CAPA, audits, document control, nonconformance, supplier management, and risk assessment. Its no-code, configurable platform allows users to build custom workflows, forms, and reports without programming expertise. It ensures compliance with standards like ISO 9001, FDA 21 CFR Part 11, and AS9100 through automated controls and electronic signatures.

ZenQMS is a cloud-based electronic Quality Management System (eQMS) designed specifically for highly regulated industries like medical devices, biotech, and pharmaceuticals. It provides comprehensive tools for document control, CAPA management, training tracking, audits, complaints, and supplier management to ensure compliance with standards such as FDA 21 CFR Part 11, ISO 13485, and EU MDR. The platform emphasizes configurable workflows, real-time collaboration, and audit-ready reporting to streamline quality processes.