Top 10 Best Quality And Compliance Management Software of 2026

ETQ Reliance is a leading cloud-based Enterprise Quality Management System (EQMS) that centralizes quality processes including CAPA, audits, complaints, document control, supplier management, risk assessment, and training. It ensures compliance with standards like ISO 9001, FDA 21 CFR Part 11, and IATF 16949 through configurable workflows and robust reporting. Designed for scalability, it supports industries like life sciences, manufacturing, and automotive with AI-driven insights and real-time analytics.

MasterControl is a comprehensive Quality Management System (QMS) software tailored for regulated industries like life sciences, manufacturing, and medical devices. It streamlines processes such as document control, CAPA, change management, audits, training, and complaint handling to ensure compliance with FDA 21 CFR Part 11, ISO 13485, and other standards. The platform offers both cloud-based and on-premise deployments, with strong automation and reporting capabilities to enhance operational efficiency and risk management.

Qualio is a cloud-based electronic Quality Management System (eQMS) designed specifically for life sciences companies, including biotech, pharma, and medtech firms. It streamlines core quality processes such as document control, training management, CAPA, non-conformances, supplier quality, audits, and complaints to ensure compliance with regulations like FDA 21 CFR Part 11, ISO 13485, and EU MDR. The platform emphasizes rapid deployment, intuitive workflows, and scalability to help organizations transition from paper-based or legacy systems efficiently.

Veeva QualityOne is a cloud-based Quality Management System (QMS) tailored for life sciences industries, offering end-to-end solutions for quality events, audits, CAPA, complaints, training, and supplier management. It ensures compliance with stringent regulations like FDA 21 CFR Part 11, ISO standards, and GxP requirements through unified processes and digital validation. Integrated with the Veeva Vault platform, it provides seamless data management and analytics to drive continuous improvement and risk-based decision-making.

ComplianceQuest is a comprehensive cloud-based Quality Management System (QMS) built natively on the Salesforce platform, designed to streamline quality processes, ensure regulatory compliance, and drive continuous improvement. It offers modules for CAPA, audits, complaints management, document control, training, supplier quality, and risk management, supporting standards like ISO 9001, FDA 21 CFR Part 11, and IATF 16949. Leveraging Salesforce's scalability and ecosystem, it enables seamless integration with CRM, ERP, and other enterprise tools for enhanced visibility and efficiency.

Greenlight Guru is a cloud-based electronic Quality Management System (eQMS) software tailored specifically for the medical device and life sciences industries. It facilitates compliance with FDA 21 CFR Part 820, ISO 13485, and other regulations through integrated modules for document control, risk management, CAPA, audits, training, and design controls. The platform emphasizes traceability, audit readiness, and accelerating time-to-market for regulated products.

AssurX is an enterprise-grade quality and compliance management software tailored for regulated industries like life sciences, manufacturing, medical devices, and insurance. It provides a unified platform for managing CAPA, audits, complaints, document control, training, risk, and supplier quality with deep configurability. The solution ensures adherence to standards such as FDA 21 CFR Part 11, ISO 13485, and GxP through automated workflows, real-time analytics, and seamless integrations.

TrackWise Digital is a cloud-based Quality Management System (QMS) from Honeywell, tailored for regulated industries like life sciences, manufacturing, and medical devices. It provides end-to-end management of quality processes including events, CAPA, complaints, audits, supplier quality, training, and risk assessment. The platform features configurable workflows, AI-powered insights, and robust reporting to ensure compliance with FDA 21 CFR Part 11, EMA, and ISO standards.

Pilgrim SmartSolve, now part of Hexagon, is a robust enterprise Quality Management System (QMS) software that centralizes quality processes including document control, audits, CAPA, complaints, supplier management, and training. It ensures regulatory compliance for industries like manufacturing, life sciences, and aerospace through configurable workflows, real-time analytics, and risk-based approaches. Available as cloud-based or on-premise, it scales to support global operations with strong integration capabilities.

Dot Compliance is a cloud-native electronic Quality Management System (eQMS) platform designed for life sciences organizations to manage GxP compliance, quality processes, and regulatory requirements. It offers configurable modules for document control, training management, CAPA, audits, risk assessments, supplier management, and change control, all within a fully validated environment. The platform emphasizes no-code customization, AI-assisted workflows, and seamless scalability for global teams.