Top 10 Best Life Sciences Compliance Software of 2026

Veeva Vault Quality is a cloud-native Quality Management System (QMS) tailored for life sciences companies, enabling end-to-end management of quality processes including CAPA, complaints, audits, deviations, training, and supplier quality. It ensures compliance with stringent regulations like FDA 21 CFR Part 11, EU Annex 11, and GxP standards through validated, configurable workflows and electronic signatures. The platform integrates seamlessly with other Veeva Vault applications for a unified source of truth, supporting global operations with real-time analytics and AI-driven insights.

MasterControl is a robust quality management system (QMS) software tailored for life sciences industries, including pharmaceuticals, biotech, and medical devices, to manage compliance with regulations like FDA 21 CFR Part 11, ISO 13485, and EU Annex 11. It provides an integrated suite of tools for document control, CAPA, training management, audit tracking, change control, and complaint handling, automating workflows to ensure audit readiness and process efficiency. The platform supports both on-premise and cloud deployments, with strong emphasis on electronic signatures and data integrity.

Qualio is a cloud-native electronic Quality Management System (eQMS) designed specifically for life sciences companies in biotech, pharma, and medtech to manage compliance and quality processes efficiently. It provides robust tools for document control, training management, CAPA, change control, audits, and supplier qualification, all validated for regulations like FDA 21 CFR Part 11, ISO 13485, and EU MDR. Qualio stands out with its modern interface and automation, enabling faster implementation compared to legacy systems while maintaining full audit traceability.

ComplianceQuest is a cloud-based Quality Management System (QMS) built on the Salesforce platform, tailored for life sciences and regulated industries to manage compliance processes like CAPA, audits, document control, complaints, training, and supplier management. It ensures adherence to FDA 21 CFR Part 11, ISO 13485, and GxP standards through automated workflows and real-time analytics. The software leverages Salesforce's scalability for customizable, no-code configurations to streamline quality operations.

Greenlight Guru is a cloud-based electronic Quality Management System (eQMS) platform purpose-built for medical device companies in the life sciences sector. It automates and interconnects critical compliance processes such as design controls, risk management (ISO 14971), CAPA, audits, complaints, and supplier management to meet FDA 21 CFR Part 820 and ISO 13485 requirements. The software promotes a proactive quality culture with real-time reporting, traceability, and collaboration tools tailored to the medtech lifecycle.

ETQ Reliance is a configurable, cloud-based enterprise quality management system (QMS) tailored for regulated industries like life sciences, enabling compliance with FDA 21 CFR Part 11, ISO 13485, and other standards. It streamlines processes such as CAPA, audits, complaints, document control, supplier management, and training through no-code workflows. The platform supports risk-based quality management and integrates with ERP and MES systems for end-to-end visibility.

AssurX is an enterprise-quality management system (EQMS) designed for life sciences organizations to manage compliance, quality events, risks, and regulatory requirements like FDA 21 CFR Part 11 and ISO standards. It provides configurable workflows for CAPA, complaints, audits, training, supplier management, and document control, ensuring audit readiness and process efficiency. The platform unifies quality processes in a single system to reduce silos and support global operations.

ValGenesis is a cloud-based Digital Validation Lifecycle Management System (VLMS) tailored for life sciences companies, enabling fully paperless validation processes compliant with FDA 21 CFR Part 11, EU Annex 11, and GxP standards. It automates validation planning, execution, review, and reporting with no-code configuration tools, real-time collaboration, and embedded electronic signatures. The platform reduces validation timelines by up to 70% while maintaining audit-ready traceability throughout the lifecycle.

Dot Compliance is a cloud-native SaaS platform designed specifically for life sciences organizations to streamline computerized system validation (CSV), quality management, and regulatory compliance. It provides pre-validated tools for electronic signatures, audit trails, document control, CAPA, training, and change management, ensuring adherence to FDA 21 CFR Part 11, EU Annex 11, and GxP standards. The platform automates validation lifecycles, reducing manual effort and accelerating go-live times for GxP systems.

Ideagen Quality Management is a comprehensive enterprise QMS platform tailored for life sciences, providing modules for document control, CAPA, audits, training management, and risk assessment to ensure GxP, FDA 21 CFR Part 11, and ISO compliance. It streamlines quality processes across manufacturing, R&D, and supply chain operations in regulated environments. The cloud-based solution integrates with ERP and LIMS systems for seamless data flow and audit readiness.