Top 10 Best Pharma Quality Management Software of 2026

MasterControl is a comprehensive quality management system (QMS) software designed specifically for highly regulated industries like pharmaceuticals, biotechnology, and medical devices. It offers an integrated suite of modules for document control, CAPA, audit management, training, supplier quality, complaints, and non-conformance handling, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, ISO 13485, and other standards. The platform automates quality processes, enhances visibility across operations, and supports digital transformation to reduce risks and improve efficiency in pharma manufacturing.

Veeva Vault Quality is a cloud-based Quality Management System (QMS) tailored for the pharmaceutical, biotech, and life sciences industries. It unifies key quality processes such as document control, CAPA, complaints, audits, training, supplier management, and risk-based monitoring within a single, validated platform. Built on the Veeva Vault architecture, it ensures global regulatory compliance (e.g., 21 CFR Part 11, Annex 11) and supports seamless integration with other Veeva applications for R&D, manufacturing, and commercial operations.

Honeywell TrackWise Digital is a cloud-native Quality Management System (QMS) designed specifically for the pharmaceutical and life sciences industries. It provides end-to-end automation for critical processes including CAPA, deviations, complaints, audits, change control, and supplier management, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and other global regulations. Leveraging AI, machine learning, and advanced analytics, it delivers predictive insights, real-time dashboards, and configurable no-code workflows to enhance quality operations and reduce risks proactively.

ETQ Reliance is a cloud-based Enterprise Quality Management System (EQMS) tailored for regulated industries like pharmaceuticals, offering end-to-end solutions for CAPA, complaints, audits, document control, supplier management, and risk-based processes. It ensures compliance with FDA 21 CFR Part 11, EU Annex 11, ISO 13485, and GxP standards through validated workflows, electronic signatures, and audit trails. The platform's no-code configurability allows pharma organizations to adapt it to unique processes without extensive programming.

ComplianceQuest is a cloud-based eQMS platform built natively on Salesforce, tailored for pharmaceutical and life sciences companies to manage quality processes in compliance with FDA 21 CFR Part 11, Part 820, and ISO standards. It offers a full suite of modules including CAPA, complaints handling, document control, audits, training management, supplier quality, nonconformance, and change control. The software emphasizes configurable workflows, electronic signatures, and audit trails to streamline validation and regulatory submissions.

Qualio is a cloud-based electronic Quality Management System (eQMS) designed specifically for life sciences companies in pharma, biotech, and medtech. It streamlines core quality processes including document control, training management, CAPA, audits, supplier quality, and change control while ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, ISO 13485, and GxP standards. Its modern, intuitive platform emphasizes ease of adoption and automation to reduce manual work.

Ideagen Quality Management is a modular QMS platform tailored for regulated industries like pharmaceuticals, offering tools for audit management, CAPA, document control, and compliance training to ensure GxP adherence. It supports FDA 21 CFR Part 11 and EU Annex 11 with features like electronic signatures, audit trails, and validation capabilities. The suite, including products like Corago and Corax, enables scalable deployment for quality processes across the pharma lifecycle.

ValGenesis is a cloud-based digital validation platform tailored for pharmaceutical, biotech, and life sciences companies to manage the entire validation lifecycle without paper. It supports paperless validation of equipment, processes, systems, and facilities, incorporating risk-based approaches, electronic signatures, and audit trails for full GxP compliance with FDA 21 CFR Part 11 and EU Annex 11. The software streamlines validation execution, approvals, and reporting, significantly reducing timelines and errors associated with traditional methods.

AssurX is a configurable enterprise quality management system (QMS) tailored for regulated industries like pharmaceuticals, offering unified management of quality events, CAPA, audits, complaints, supplier quality, and training. It leverages a single data model to streamline processes, ensure compliance with FDA 21 CFR Part 11, EMA, and ISO standards, and provide real-time analytics. The platform's no-code configuration allows pharma organizations to adapt workflows to specific needs without extensive IT involvement.

Pilgrim SmartSolve is an enterprise quality management system (eQMS) tailored for regulated industries like pharmaceuticals, offering modules for CAPA, audits, complaints, document control, training, and supplier management. It ensures compliance with FDA 21 CFR Part 11, EU Annex 11, and other global standards through automated workflows and electronic signatures. The platform provides configurable dashboards and analytics to drive continuous improvement and risk mitigation in quality processes.