Top 10 Best Fda Regulatory Compliance Software of 2026

Veeva Vault Quality is a cloud-native Quality Management System (QMS) tailored for life sciences organizations, enabling end-to-end management of quality processes like document control, CAPA, audits, complaints, training, and supplier management. It ensures full compliance with FDA regulations including 21 CFR Part 11, Annex 11, and GxP standards through validated electronic signatures, audit trails, and configurable workflows. The platform's unified architecture integrates seamlessly with other Veeva Vault applications for clinical, regulatory, and commercial operations, reducing silos and accelerating compliance.

MasterControl is a comprehensive Quality Management System (QMS) software designed specifically for FDA-regulated industries like pharmaceuticals, medical devices, and biotechnology. It automates critical processes such as document control, CAPA, training management, audits, complaints, and supplier management to ensure compliance with 21 CFR Part 11, Part 820, and other regulations. The platform provides electronic signatures, audit trails, and validated workflows to minimize risks, streamline operations, and support faster FDA submissions.

Greenlight Guru is a cloud-based electronic Quality Management System (eQMS) tailored exclusively for medical device companies, enabling streamlined management of FDA regulatory compliance processes. It offers modules for document control, risk management, CAPA, audits, training, and change control, all pre-configured to align with 21 CFR Part 820, ISO 13485, and other medtech standards. The platform helps teams maintain audit readiness, automate workflows, and accelerate time-to-market while ensuring traceability and electronic signatures compliant with 21 CFR Part 11.

Qualio is a cloud-based electronic Quality Management System (eQMS) tailored for life sciences companies, enabling compliance with FDA 21 CFR Part 11, EU Annex 11, and ISO 13485 standards. It centralizes document control, training management, CAPA, non-conformances, change control, audits, and supplier quality in a unified platform. The software emphasizes rapid implementation and scalability, helping regulated teams maintain audit-ready quality processes without extensive customization.

TrackWise, from Sparta Systems (now part of Honeywell), is an enterprise quality management system (eQMS) tailored for life sciences industries to manage FDA regulatory compliance. It offers configurable modules for CAPA, complaints, audits, change control, training, and document management, ensuring adherence to 21 CFR Part 11, Part 820, and other GxP requirements with robust audit trails and electronic signatures. The platform supports end-to-end quality processes, helping organizations streamline operations and reduce compliance risks.

ETQ Reliance is a configurable, enterprise-grade Quality Management System (QMS) designed for regulated industries, including life sciences, to manage FDA compliance requirements such as 21 CFR Part 11, CAPA, audits, and document control. It offers modules for non-conformance management, supplier quality, training, and risk-based processes, enabling organizations to streamline quality operations and ensure audit readiness. The platform's no-code tools allow deep customization to fit specific workflows without developer intervention.

ComplianceQuest is a cloud-based Quality Management System (QMS) built on the Salesforce platform, tailored for FDA-regulated industries like life sciences and medical devices. It provides end-to-end compliance tools including CAPA management, complaint handling, audit tracking, document control, training management, and supplier quality oversight, all supporting 21 CFR Part 11 with electronic signatures and validation. The software automates quality processes to minimize risks, ensure traceability, and facilitate regulatory submissions.

AssurX is an enterprise-grade quality management system (eQMS) tailored for regulated industries like pharmaceuticals, medical devices, and biotechnology to ensure FDA compliance. It provides configurable modules for CAPA, complaints handling, audits, training, document control, and risk management, all supporting 21 CFR Part 11 electronic signatures and audit trails. The platform enables unified quality processes across the organization, reducing silos and improving operational efficiency in highly regulated environments.

ValGenesis is a digital validation lifecycle management system (VLMS) tailored for the life sciences industry, enabling fully paperless validation processes compliant with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines. It streamlines validation planning, risk assessment, protocol execution, deviation management, and reporting through a configurable, no-code platform. The software supports real-time collaboration, electronic signatures, and audit trails to ensure regulatory compliance and accelerate time-to-market for pharma and biotech products.

Ideagen Quality Management is a robust enterprise-grade Quality Management System (QMS) designed for regulated industries, including pharmaceuticals and medical devices, to ensure compliance with FDA regulations such as 21 CFR Part 11. It provides modules for document control, audit management, CAPA, non-conformance handling, risk management, and supplier quality oversight, all with full audit trails and electronic signatures. The platform supports validation processes and integrates with ERP systems to streamline compliance workflows.