Quality Management System SoftwareReviews and Ratings
What is Quality Management System Software?
Gartner defines the market for quality management system (QMS/eQMS) software as stand-alone digital solutions with embedded emerging technological capabilities that enable organizations to systematically manage, monitor and improve the quality of their products, processes and services. These software solutions help organizations meet customer quality expectations and maintain compliance with international standards as well as industry-specific regulations.
QMS software is designed to help organizations reduce waste, lower costs, house quality documents, assess risk, track performance, ensure compliance and improve processes. The QMS/eQMS market serves a broad spectrum of industries, including manufacturing, life sciences, automotive, aerospace and defense, electronics, food and beverage, chemicals, consumer packaged goods, services, and more. These solutions are built to help organizations of all sizes, from single facilities to complex, global operations, establish a consistent approach to managing and enhancing the quality of products, processes and services throughout the value chain.
SAP Cloud ERP (formerly SAP S/4HANA Cloud) is a modular enterprise resource planning (ERP) software, powered by AI and analytics, that integrates core business functions including finance, supply chain, manufacturing, procurement, and sales. It enables users to run mission-critical operations in real time from anywhere, introduce new business models in any industry, and expand globally.
SAP Cloud ERP is a SaaS product and can also be deployed in a hybrid landscape for quicker time to value. SAP Cloud ERP is the foundational component of the SAP Business Suite, a seamlessly integrated system of applications, data, and AI that connects and optimizes every part of your business, enabling smarter decisions, real-time insights, and intelligent automation.
MasterControl Quality Excellence is built on an AI-driven platform, enables life-sciences companies to enable flexible quality event management, simplified document management, and automated training management—that all work seamlessly together to close the loop on quality.
Targeted primarily at quality professionals within the life sciences industry, MasterControl Qx serves a diverse range of organizations, from pharmaceuticals to biotechnology and medical devices. These industries often face stringent regulatory requirements and complex quality assurance processes. MasterControl Qx offers a centralized platform that integrates various quality management functions, allowing users to manage quality events, documentation, training, and audits seamlessly. This integration not only enhances operational efficiency but also ensures that organizations remain compliant with industry standards.
ETQ Reliance is a cloud-native, enterprise-grade Quality Management System (QMS) designed to empower quality teams across the value chain. With 40+ configurable applications, it supports core functions like document control, CAPA, audits, risk management, and training. Its flexible, no-code platform enables rapid deployment and global scalability. ETQ Reliance integrates seamlessly with business and operations systems, like ERP, MES and Connected Worker platforms, extending quality processes to the shop floor. Advanced analytics and AI-driven insights help reduce cost of poor quality, accelerate time to market, and ensure compliance. Built on AWS with robust security, it supports ISO 9001, 27001, and other standards. ETQ Reliance helps organizations drive continuous improvement and strategic decision-making.
Windchill is a product lifecycle management software developed for enterprise use to manage product data and processes. The software offers capabilities for collaboration, configuration management, change and document management, bill of materials management, and compliance tracking throughout the product development lifecycle. Windchill is designed to improve product quality and align engineering, manufacturing, and service teams by enabling access to a centralized source of product information. The software supports version control, workflow automation, and process standardization while providing tools for secure data sharing and integration with other enterprise applications. Organizations implement this software to streamline product development, manage complex product structures, and facilitate regulatory compliance.
AlisQI is an easy to implement and integrate, no-code cloud-based Quality Management platform. It combines Quality Control & SPC, Quality Assurance and EHS management in a single, integrated but modular solution. Customers can implement the software themselves, which eliminates the need for long and expensive implementation projects.
Oracle Fusion Cloud Product Lifecycle Management (PLM) software supports businesses in managing the entire lifecycle of a product from concept through design, manufacturing, compliance, and service. The software offers features for product data management, bill-of-material creation, change management, quality control, and collaboration among stakeholders. It provides integrated workflows and analytics that enable organizations to streamline product development processes, enhance visibility into product information, ensure regulatory compliance, and reduce time to market. The software is designed to address the need for centralized product data and process management, supporting improved efficiency and decision-making throughout a product’s lifecycle.
AssurX Enterprise Quality Management Software is designed to help organizations manage and automate quality and compliance processes across various industries. The software offers tools for document control, change management, audits, risk management, training, supplier quality, corrective and preventive actions, complaint handling, EH&S and regulatory reporting. By providing centralized management of quality data and processes, the software enables organizations to maintain compliance with industry standards and regulations, improve operational efficiency, and reduce the risk of nonconformance. It facilitates real-time visibility into quality metrics, supports workflow automation, and integrates with other business systems to streamline quality operations.
EASE is a software designed to streamline and manage manufacturing plant floor processes, including layered process audits, safety inspections, and quality control activities. The software provides tools for scheduling, conducting, and tracking audits and inspections, automating data collection and analysis to help organizations identify and address issues related to compliance, operational efficiency, and product quality. EASE facilitates the reporting and visualization of audit results, supports corrective action management, and integrates with existing enterprise systems, aiming to improve oversight and consistency in manufacturing operations while addressing challenges related to manual documentation and inefficient process tracking.
Intellect’s QMS AI platform is ISO certified, reinforcing our commitment to quality teams for operational excellence and the highest standards of quality processes and compliance to reduce risks. Intellect's solutions and apps are compliance-ready and built specifically for Manufacturing and Life Sciences industries that are highly-regulated, such as for Automotive, Logistics, Supply Chain to Pharmaceuticals. The quality management systems software is a no code solution and is built to be pre-ready for most business needs, although it can adapt through customization for business specifications. For example, Intellect QMS AI software keeps proprietary supply chain data encrypted, secure, and centralized without additional coding. Gives control to quality leaders without compromising compliance.
ComplianceQuest is a cloud-based software designed to support enterprise quality and compliance management. The software facilitates document control, audit management, risk assessment, corrective and preventive actions, supplier management, and customer complaint handling. By streamlining regulatory processes and centralizing quality data, it helps businesses address challenges related to maintaining industry compliance and managing operational risks. The software is built on the Salesforce platform, enabling integration with other business applications and providing configurable workflows to meet specific regulatory requirements. It aims to support organizations in staying compliant with global standards and improving overall process efficiency.
Veeva Quality Cloud is a software designed to support quality management processes within regulated industries such as life sciences. The software offers capabilities for document control, change management, training management, and CAPA (Corrective and Preventive Actions) to help organizations maintain compliance with regulatory standards. It centralizes quality data and processes, enabling users to manage and track quality events, audits, and risk assessments. The software is cloud-based, facilitating real-time collaboration across multiple locations and providing secure access to quality information. Veeva Quality Cloud is intended to streamline quality operations, reduce manual processes, and improve visibility into quality performance across an organization.
Enterprise-wide Quality and Integrated Management System (EwQIMS) is a software designed to support businesses in managing and improving quality processes across various departments. The software enables the integration of quality systems, risk management, compliance, document control, auditing, corrective actions, and continual improvement functions within an organization. EwQIMS helps organizations align their operations with industry standards by centralizing data, streamlining workflows, and automating reporting. The software aims to reduce operational risks, maintain regulatory compliance, improve traceability, and ensure consistency in quality management practices throughout the enterprise.
Ideagen's Quality Management solution is a complete quality, compliance and document management software system which can help organisations automate business processes, manage and control documents, and comply with industry specific standards and regulations. The user-friendly solution provides a single source of truth for all relevant documentation, data, materials and activities associated with the quality process.
Modules include: Documents, Audits, Issues, Risks, Training & Competence, Assets & Equipment, Interested Parties, Law plus a specialized edition for Food and Beverage supply chain quality management.
TrackWise QMS is a software designed to support organizations in managing and automating quality processes such as document control, audit management, CAPA, change control, and complaint handling. It provides a centralized platform to facilitate compliance with regulatory requirements and enables integration of quality data across departments and sites. The software offers configurable workflows and reporting tools to help businesses monitor quality metrics and address nonconformances. TrackWise QMS aims to improve operational efficiency by standardizing processes and supporting traceability of quality records throughout the product lifecycle.
Intelex Quality Management Software is designed to help organizations manage and streamline quality processes and compliance requirements. The software facilitates document control, audit management, corrective and preventive action tracking, and performance monitoring. It supports integration with other business systems to enhance data visibility and reporting capabilities. The software aims to address business challenges related to maintaining regulatory compliance, managing risks, and improving overall operational efficiency by standardizing quality management activities and automating routine tasks.
Ideagen EHS is a software designed to help organizations manage environmental, health, and safety compliance requirements. The software enables users to track incidents, conduct audits and inspections, monitor corrective actions, and manage risk assessments. It offers tools for reporting, document control, and performance analysis to support regulatory adherence and continuous improvement. Ideagen EHS addresses business challenges related to workplace safety, regulatory compliance, and operational risk by centralizing data and automating workflows, making it easier for businesses to meet EHS obligations and enhance overall safety management processes.
Siemens QMS is a comprehensive solution native in Teamcenter and Opcenter X platforms, delivering quality and compliance management across the product lifecycle and manufacturing operations. Built on a modular, scalable architecture, it provides core capabilities such as Corrective and Preventive Actions (CAPA), Supplier Quality Management, Audit Management, Document Control, Training and Qualification Management. Moreover, Siemens QMS supports advanced processes including Risk Management/FMEA, APQP and PPAP, Model-based Characteristics, Variation Analysis, Measurement System Analysis, Inspection Management, SPC, Analytics, Non-Conformance and Quality Action Management, enabling end-to-end quality across the product lifecycle. By aligning with standards like ISO 9001 and leveraging AI features, Siemens QMS solution empowers manufacturers to enhance efficiency, mitigate risk and foster a culture of continuous improvement to achieve excellence in quality and compliance across industries.
Greenlight Guru QMS is a software designed for medical device companies to manage quality processes in compliance with industry regulations and standards. The software offers tools for document management, design controls, risk management, training management, and audit management. It facilitates automation of quality workflows, enables traceability, and provides dashboards and reporting to support decision-making. Greenlight Guru QMS aims to streamline processes related to product development and post-market activities. The software addresses the need for structured quality assurance, reducing manual tasks and supporting regulatory submission requirements.
QAD EQMS is a software designed to facilitate enterprise quality management by providing tools to control, monitor, and improve quality and compliance processes within an organization. The software offers modules for managing corrective and preventive actions, nonconformance, audits, document control, supplier quality, and risk assessment. QAD EQMS enables organizations to standardize quality processes, ensure compliance with industry regulations, and enhance visibility into quality-related data. The software helps streamline collaboration among teams, track and report on quality metrics, and integrate quality management activities with other enterprise systems. It aims to address challenges related to operational efficiency and regulatory compliance by providing a centralized platform for quality management activities.
Cority's Quality Management System (QMS) Software streamlines quality processes, manages nonconformance lifecycles, and supports continuous improvement initiatives. Designed by quality experts, the software integrates seamlessly with CorityOne, providing robust data collection, document control, and regulatory compliance capabilities. Trusted by 1,500 organizations worldwide, Cority's QMS solution enhances operational efficiency, delivers actionable insights, and supports data-driven decision-making. For 40 years, Cority has been dedicated to reducing risks and creating a safer, healthier, and more sustainable world. Cority's scalable and configurable platform empowers organizations to meet their quality management goals and drive better business outcomes.
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Features of Quality Management System Software
Updated January 2026
Mandatory Features:
Change, risk and analysis:
1. Change control — The system provides workflows and enforcement of processes for managing changes in quality products, processes and services.
2. Risk assessment — This refers to the process of identifying magnitude, frequency or likelihood of organizationwide quality risks.
3. Failure modes and effects analysis (FMEA) or other industry relevant analysis such as HACCP — The system provides a structured approach to discovering potential failures that may exist within the design of a product or process
Document and training:
1. Document management and control — The system is used for electronic storage, maintenance, version control and retrieval of quality documents, which may include, for example, SOPs, work instructions or engineering change orders.
2. Employee training and qualification — The system provides modules for managing responsibilities, training and certification requirements for employees, suppliers and other partners to monitor and ensure compliance with regard to required training and certification.
Must maintain compliance with international standards such as ISO 9001, as well as industry-specific regulations such as those from the U.S. Food and Drug Administration (FDA) and the Federal Acquisition Regulation (FAR).
Customer and supplier:
1. Complaint management — The system provides a workflow to log, manage and track the status of customer complaints.
2. Supplier quality management (SQM) — The system provides tools for measuring and managing the quality of direct material suppliers and external manufacturing service providers.
Core quality:
1. Corrective and preventive action (CAPA) — The system provides workflow support to respond to a nonconforming or unplanned event through investigation, action plan development, implementation of preventive actions and ensuring no risk of recurrence.
2. Nonconformance management — This refers to Identifying, documenting and resolving instances where products or processes do not meet requirements.
3. Deviations management — This refers to recording and managing departures from approved procedures,
4. Audit management — This pertains to planning, executing and tracking audits to ensure quality standards and regulatory compliance are maintained.
Peer Lessons Learned for Quality Management System Software
Published February 2025
These lessons focuses on the responses to the questions: “If you could start over, what would your organization do differently?” and “What one piece of advice would you give other prospective customers?”