Top 10 Best Healthcare Regulatory Compliance Software of 2026

MasterControl is a comprehensive electronic quality management system (eQMS) designed specifically for regulated industries like healthcare and life sciences to ensure compliance with FDA 21 CFR Part 11, ISO 13485, EU MDR, and other standards. It provides integrated modules for document control, CAPA, audit management, change control, training, complaints, and supplier management, with automated workflows and robust audit trails. The platform supports both cloud and on-premise deployments, enabling seamless scalability and integration with ERP, LIMS, and manufacturing systems to streamline quality processes and mitigate compliance risks.

ETQ Reliance is a cloud-based Enterprise Quality Management System (EQMS) tailored for regulated industries, including healthcare, to streamline compliance with FDA 21 CFR Part 11, ISO 13485, HIPAA, and GxP standards. It provides configurable modules for CAPA, audits, complaints, document control, training, and supplier management, enabling proactive risk mitigation and quality assurance. The platform's no-code tools allow healthcare organizations to customize workflows rapidly without IT dependency, supporting digital validation and traceability.

ComplianceQuest is a cloud-based Enterprise Quality Management System (EQMS) built natively on the Salesforce platform, tailored for regulated industries like healthcare to manage compliance workflows. It provides comprehensive tools for audits, CAPA, complaints, document control, training, risk management, and supplier quality, ensuring adherence to standards such as FDA 21 CFR Part 11, HIPAA, ISO 13485, and GxP. The software leverages Salesforce's scalability, AI capabilities, and low-code customization to unify quality processes with CRM data for proactive compliance.

Qualio is a cloud-based electronic Quality Management System (eQMS) designed specifically for life sciences companies in biotech, pharmaceuticals, and medical devices to ensure regulatory compliance. It centralizes processes like document control, training management, CAPA, non-conformances, audits, and supplier quality in a unified platform compliant with FDA 21 CFR Part 11, EU Annex 11, ISO 13485, and GxP standards. The software prioritizes simplicity and speed, enabling rapid deployment without extensive configuration.

Greenlight Guru is a cloud-based electronic Quality Management System (eQMS) tailored exclusively for medical device companies to manage regulatory compliance throughout the product lifecycle. It provides specialized modules for document control, design controls, risk management, CAPA, audits, training, and reporting, ensuring adherence to FDA 21 CFR Part 820, ISO 13485, EU MDR, and other standards. The platform emphasizes traceability and automation to reduce manual errors and accelerate time-to-market for medtech firms.

ValGenesis is a cloud-based digital validation platform tailored for the life sciences industry, including pharmaceuticals, biotech, and medical devices, to manage the entire validation lifecycle in compliance with FDA 21 CFR Part 11 and EU Annex 11 regulations. It offers a paperless, touchless validation process through its VLMS (Validation Life Cycle Management System), enabling planning, execution, review, approval, and reporting without physical documents. The software incorporates risk-based methodologies, real-time analytics, and AI-driven insights to accelerate compliance while minimizing errors and audit risks.

NAVEX One is a unified governance, risk, and compliance (GRC) platform that streamlines ethics, compliance, and risk management for organizations, with tailored solutions for healthcare regulatory needs like HIPAA, OSHA, and FDA requirements. It offers modular tools including policy management, incident reporting via hotline, employee training, risk assessments, and audit tracking, all accessible through a single dashboard. The platform provides real-time analytics and automated workflows to help healthcare providers maintain compliance and mitigate risks efficiently.

Compliancy Group’s HIPAA ONE is a cloud-based platform specifically designed to streamline HIPAA compliance for healthcare organizations, covering risk assessments, employee training, policy templates, and incident management. It automates much of the compliance process with guided workflows, dashboards for tracking progress, and ongoing monitoring tools. The software also includes expert support and a unique compliance certification program to validate adherence.

MedTrainer is a cloud-based compliance training and management platform tailored for healthcare organizations, offering an extensive library of over 800 pre-built courses on regulations like HIPAA, OSHA, infection control, and HR topics. It provides tools for employee training tracking, competency assessments, policy distribution, incident reporting, and automated compliance calendars to ensure regulatory adherence. The software streamlines audits with detailed reporting and integrates with LMS systems for seamless workflow.

Vanta is a compliance automation platform that streamlines security and regulatory compliance for frameworks like SOC 2, ISO 27001, HIPAA, and GDPR, with strong HIPAA support for healthcare organizations. It automates evidence collection, continuous monitoring, policy management, and audit preparation by integrating with over 300 tools and services. This reduces manual effort, providing real-time compliance insights and customizable trust centers to demonstrate adherence to standards.