Top 10 Best Pharmaceutical Regulatory Compliance Software of 2026

Veeva Vault is a cloud-native platform tailored for the life sciences industry, providing end-to-end solutions for regulatory information management (RIM), quality management systems (QMS), and clinical operations to ensure pharmaceutical regulatory compliance. It supports the full regulatory lifecycle, including planning, authoring, submission publishing (eCTD, IDMP), and post-approval changes, with built-in tools for tracking global requirements and automating workflows. The platform's unified data model eliminates silos, enabling real-time collaboration and audit-ready traceability across multinational teams.

MasterControl is a robust enterprise Quality Management System (QMS) tailored for pharmaceutical and life sciences industries, offering end-to-end solutions for regulatory compliance including document control, CAPA, audit management, training, and supplier quality. It ensures adherence to stringent regulations like FDA 21 CFR Part 11, ISO 13485, and EU Annex 11 through automated workflows, electronic signatures, and validation tools. The platform integrates quality processes to minimize risks, accelerate time-to-market, and enhance operational efficiency in highly regulated environments.

Honeywell TrackWise Digital is a cloud-native Quality Management System (QMS) tailored for the pharmaceutical and life sciences industries to ensure regulatory compliance. It manages end-to-end processes including deviations, investigations, CAPA, change control, audits, complaints, and supplier quality through configurable workflows and electronic signatures. Powered by AI and machine learning via Honeywell Quality Intelligence, it delivers predictive analytics, automated decision-making, and real-time insights to proactively mitigate risks and accelerate compliance.

ETQ Reliance is a cloud-native Quality Management System (QMS) tailored for regulated industries like pharmaceuticals, enabling end-to-end compliance with standards such as 21 CFR Part 11, ISO 13485, and GxP requirements. It automates key processes including CAPA, audits, document control, training management, complaints handling, and supplier quality. The platform's no-code configuration allows pharma teams to customize workflows rapidly without IT dependency, ensuring audit-ready traceability and real-time analytics.

ComplianceQuest is a cloud-based Enterprise Quality Management System (eQMS) built natively on the Salesforce platform, tailored for pharmaceutical and life sciences companies to manage regulatory compliance. It offers modules for CAPA, audits, complaints, nonconformance, document control, supplier quality, training, and risk management, ensuring adherence to FDA 21 CFR Part 11, ISO 13485, and other standards. The software leverages Salesforce's scalability and security for streamlined workflows and real-time collaboration.

ValGenesis is a specialized digital validation platform tailored for the pharmaceutical, biotech, and life sciences industries, enabling end-to-end paperless validation lifecycle management. It supports validation master planning, protocol authoring and execution, risk assessments, change control, and deviation management, all fully compliant with FDA 21 CFR Part 11, EU Annex 11, and other global regulations. The software streamlines compliance processes, reduces manual errors, and accelerates time-to-market for regulated products through real-time collaboration and audit-ready reporting.

Qualio is a cloud-based electronic Quality Management System (eQMS) designed specifically for life sciences companies in pharmaceuticals, biotech, and medtech to ensure regulatory compliance with standards like FDA 21 CFR Part 11, EU Annex 11, and ISO 13485. It provides integrated modules for document control, training management, CAPA, non-conformances, change control, supplier quality, and audits, all accessible via a modern, intuitive interface. Qualio emphasizes rapid deployment and ease of use, helping teams maintain audit-ready quality systems without the overhead of legacy QMS software.

IQVIA SmartSolve is a robust electronic Quality Management System (eQMS) tailored for the pharmaceutical, biotech, and medical device industries, enabling end-to-end management of quality processes to ensure regulatory compliance with FDA, EMA, and global standards. It provides modular solutions for document control, CAPA, audits, complaints, supplier management, training, and risk assessment, all within a configurable, scalable platform. Leveraging IQVIA's extensive life sciences expertise, it helps organizations streamline operations, mitigate risks, and accelerate time-to-market while maintaining audit readiness.

AssurX is a comprehensive enterprise quality management system (EQMS) tailored for regulated industries like pharmaceuticals, offering modules for quality events, CAPA, audits, change control, complaints, and supplier management. It supports compliance with FDA 21 CFR Part 11, EU Annex 11, and other global regulations through configurable workflows, automated notifications, and robust reporting. The platform enables a unified view of quality processes, reducing silos and improving risk-based decision-making in complex manufacturing environments.

SimplerQMS is a cloud-based Quality Management System (QMS) tailored for pharmaceutical, biotech, and medical device companies, offering modules for electronic document management, training, CAPA, audits, complaints, and supplier management. It ensures compliance with key regulations like FDA 21 CFR Part 11, EU Annex 11, ISO 13485, and GxP standards through validated workflows and audit trails. The platform emphasizes no-code configuration and rapid deployment, making it suitable for digitizing quality processes without heavy IT involvement.