Top 10 Best Product Compliance Management Software of 2026

Assent is a leading supply chain compliance platform that helps enterprises manage product compliance across global regulations like RoHS, REACH, Prop 65, and conflict minerals. It automates supplier data collection, substance tracking, and reporting while providing deep visibility into multi-tier supply chains. The software integrates with ERP and PLM systems to streamline workflows and mitigate risks associated with ESG and regulatory requirements.

MasterControl is a comprehensive Quality Management System (QMS) platform tailored for product compliance in regulated industries like life sciences and manufacturing. It automates key processes including document control, CAPA, audit management, training, and supplier quality to ensure adherence to standards such as FDA 21 CFR Part 11, ISO 13485, and EU MDR. The software provides a unified, connected quality ecosystem that reduces compliance risks, accelerates approvals, and enhances operational efficiency through configurable workflows and robust validation support.

Veeva Quality is a cloud-based Quality Management System (QMS) suite tailored for life sciences industries, including pharmaceuticals and biotech. It provides modules for document control (QualityDocs), training management, CAPA, complaints, audits, and supplier quality to ensure compliance with regulations like FDA 21 CFR Part 11, EU Annex 11, and ISO standards. The platform streamlines quality processes, reduces compliance risks, and supports global operations with real-time visibility and collaboration.

ETQ Reliance is a cloud-based enterprise quality management system (QMS) focused on product compliance, regulatory affairs, and quality processes. It provides configurable modules for document control, audit management, CAPA, supplier qualification, risk assessment, and non-conformance tracking to ensure products meet standards like ISO 13485, FDA 21 CFR Part 11, and EU MDR. The platform emphasizes no-code customization, enabling organizations to adapt workflows to specific compliance needs without developer involvement.

Qualio is a cloud-based electronic Quality Management System (eQMS) tailored for life sciences companies, enabling streamlined management of quality processes like document control, training, CAPA, audits, and supplier management. It ensures compliance with stringent regulations such as FDA 21 CFR Part 11, ISO 13485, and EU MDR through automated workflows, electronic signatures, and full audit trails. Designed for scalability, it supports growing organizations from startups to enterprises with a modern, intuitive interface.

Greenlight Guru is a cloud-based electronic Quality Management System (eQMS) tailored exclusively for medical device companies, enabling streamlined compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971. It provides interconnected modules for design controls, risk management, CAPA, change management, audits, training, and post-market surveillance to manage the entire product lifecycle. The platform automates documentation, traceability, and reporting to reduce compliance risks and accelerate time-to-market.

ComplianceQuest is a cloud-based Enterprise Quality Management System (eQMS) built natively on the Salesforce platform, specializing in product compliance management for regulated industries like manufacturing, life sciences, and automotive. It streamlines processes such as document control, audits, CAPA, risk management, supplier quality, and nonconformance reporting to ensure adherence to standards like ISO 13485, FDA 21 CFR Part 11, and IATF 16949. The software provides real-time visibility into compliance status across the product lifecycle, with robust analytics and automation to reduce risks and accelerate regulatory approvals.

Intelex is a robust EHSQ (Environment, Health, Safety, and Quality) management platform with dedicated Product Stewardship modules for product compliance management. It enables tracking of substances, supplier declarations, regulatory requirements like REACH, RoHS, and TSCA, and automates compliance reporting and audits. The software supports configurable workflows, risk assessments, and integrations to centralize product data across the supply chain.

MetricStream is a comprehensive enterprise GRC platform that supports product compliance management by enabling organizations to track regulatory changes, automate compliance assessments, and manage product certifications across global standards like FDA, ISO, and REACH. It integrates risk management, audit tracking, and supplier compliance to streamline the product lifecycle from design to market. The platform leverages AI for predictive insights, helping teams proactively address compliance gaps and reduce non-conformance risks.

Archer is an enterprise-grade Integrated Risk Management (IRM) platform that supports product compliance management through configurable modules for regulatory tracking, audit management, and risk assessments. It enables organizations to centralize compliance data, automate workflows for standards like RoHS, REACH, and FDA requirements, and monitor supplier adherence across the product lifecycle. While highly scalable, its general GRC focus requires customization for specialized product compliance needs.