16 Best Quality Management Systems (QMS) in 2024 (2025)

QMS software helps assess, maintain, and enhance product and service quality. Often, they specifically help with industry compliance standards (i.e. ISO 9001) and regulations. Some of our favorite options include:

• EtQ Reliance
• MasterControl
• Unifize

Using our advanced review methodology, our team tested most of the popular QMS systems on the market and ranked them below.

• EtQ Reliance: Best Overall
• MasterControl Qx: Best Product Lifecycle Automation
• Unifize: Best for Collaboration
• Greenlight Guru: Best for Medical Device Industry
• Qualio: Best for Life Sciences Sector
• SmartSolve eQMS: Best Postmarket Surveillance
• TrackWise: Best Reporting Tools
• uniPoint: Best ERP Integrations
• DELMIAworks: Best End-to-End Solution
• Intellect QMS: Most Adaptable Pick
• Ideagen : Best for Food and Beverage
• DELMIA Apriso: Best for Global Operations
• QT9 QMS: Best for Small Businesses
• Qualcy: Transparent Pricing Model
• Intelex : Best for EHSQ Management
• QAD EQMS: Best Supplier Management

1 EtQ Reliance - Best Overall

Why We Chose It: EtQ Reliance earned our best overall pick for quality management software. It offers wide-ranging utility in highly regulated industries such as life sciences, medical devices, pharmaceuticals, and food and beverage. It’s particularly suited for medium to large enterprises.

EtQ Reliance delivers an intuitive and adaptable interface tailored for businesses with intricate processes. The web-based software allows for quick setup and regular updates, helping companies stay agile in the ever-evolving quality control field. This blend of flexibility and user-friendliness makes EtQ Reliance a leading solution in QMS software.

2 MasterControl Qx - Best Product Lifecycle Automation

Why We Chose It: MasterControl Qx made our list because of its ability to automate and oversee the entire product lifecycle, ensuring high-quality standards from conception to delivery. It’s a quality management system that covers every phase, guaranteeing consistent quality at all stages.

What distinguishes MasterControl Qx is its suite of advanced features that enhance efficiency, including electronic document access and automated notifications. Its cloud-based setup ensures users have immediate access to the latest features and updates. Overall, MasterControl Qx is adept at automating quality management processes, helping regulated businesses accelerate market entry, cut costs, boost efficiency, reduce risks, and maintain compliance.

Industries: Pharmaceuticals, medical devices, biotechnology

3 Unifize - Best for Collaboration

Why We Chose It: Unifize is a quality management software designed to enhance teamwork within manufacturing companies, from the production area to every department. It delivers a chat-based setup, making it ideal for collaborative work. Each entry in Unifize includes a chat-like conversation thread, complete with status, an assigned owner, set priorities, and designated teams, fostering increased interaction and cooperation.

This quality control software also integrates with email and current ERP and PLM systems, positioning Unifize as a valuable supplementary tool. It supports connections with popular third-party applications such as NetSuite, Epicor, and Microsoft Dynamics 365. Additionally, its enterprise-level security features and role management capabilities ensure it can help organizations comply with regulatory standards.

Industries: Automotive, medical devices, manufacturing, food production, aerospace, cosmetics

4 Greenlight Guru - Best for Medical Device Industry

Why We Chose It: We picked Greenlight Guru because it’s tailored to the medical device industry, streamlining FDA and ISO compliance and accelerating the launch of safer products. It integrates document control with design traceability and offers tools for managing SOPs, policies, and work instructions.

Moreover, this QMS software has dynamic reporting capabilities. We found it simple to create, export, and share custom reports on quality events, design controls, and risk management activities. Users can share and personalize configurable dashboards for better project, gap, and risk analysis. Finally, Greenlight Guru supports supplier process management and enforces adherence to critical quality standards, improving product reliability for medical device manufacturers.

5 Qualio - Best for Life Sciences Sector

Why We Chose It: Qualio is an eQMS tailor-made for the life-science industries, making it an ideal solution for medical device companies, biotech/therapeutic firms, and pharmaceutical contractors. One feature of note is its ability to simplify complex processes and help businesses meet industry standards such as ISO 14971 and ICH Q9.

We found Qualio’s modern interface makes it pretty easy to use. They also provide a fast implementation plan, so users can get up and running quickly. A Qualio subscription includes all software in the package for up to 10 users, with the option to add additional users for a nominal annual fee. While there is no free trial, the pricing can accommodate various business sizes. Ultimately, the platform is adept at scaling with companies as they grow.

6 SmartSolve eQMS - Best Postmarket Surveillance

Why we chose it: SmartSolve made our list because of its postmarket surveillance module. The feature simplifies the setup and maintenance of surveillance plans and activity details, tracking each activity from data collection through to analysis and reporting. It integrates with other quality processes within the eQMS, such as CAPA, change, and risk management. Additionally, it integrates with SmartSolve Document Management to generate Post-Market Surveillance Reports (PSURs) using custom templates.

Additionally, SmartSolve offers a user-friendly dashboard that assigns tasks and owners for enhanced tracking and cross-departmental communication. This ensures that all team members have visibility into the PMS process, with real-time status updates and easy access to surveillance evidence and reports.

7 TrackWise - Best Reporting Tools

Why We Chose It: TrackWise delivers strong reporting capabilities for industries that demand rigorous quality and compliance monitoring. Its strength lies in providing granular tracking of quality incidents, deviations, and CAPAs, enabling businesses to capture and analyze detailed data at every stage.

TrackWise’s sophisticated reporting tools allow for in-depth analysis and insights. These include compliance, audit, supplier quality, and training and competency reports. TrackWise is a decent choice for organizations prioritizing detail-oriented quality management practices.

Industries: Pharmaceuticals, information technology and services, biotechnology, medical devices

8 uniPoint - Best ERP Integrations

Why We Chose It: uniPoint made our list because it has strong ERP integrations, connecting with 40 leading ERP systems right out of the box. For those needing a more tailored approach, uniPoint’s Custom Integration Module allows bespoke connections to any ODBC-compliant ERP system. This adaptability extends to its configuration options, where customers can select only the required features, avoiding the expense of unused functionalities.

This scalable solution is ideal for a range of business sizes, from startups with a minimum of ten users to mid-sized enterprises with up to a hundred employees. Unlike traditional systems that limit access to named individuals, uniPoint employs a concurrent user model, allowing unlimited users to access the system. UniPoint offers a range of core modules that manage many quality management processes, from addressing non-conformances to initiating corrective actions.

Industries: Aerospace, automotive, manufacturing, job shops, life sciences, oil and gas, food and beverage

9 DELMIAworks - Best End-to-End Solution

Why We Chose It: DELMIAworks, formerly IQMS 2200, is an advanced ERP system designed to amplify quality management operations. It bolsters defect prevention and continuous improvement efforts, integrating effortlessly with methodologies like Six Sigma DMAIC. This synergy allows for a precise, scalable quality management system that ensures reliability and consistency.

The system is instrumental in the execution, planning, and evaluation of all customer interactions, from the initial order through to product delivery. Moreover, DELMIAWorks is pivotal in helping companies maintain compliance with a wide range of quality and regulatory standards, including ISO 9001, ISO 13485, and FDA medical device registration. And it supports advanced manufacturing capabilities, such as low-particulate production, statistical process control, and cutting-edge vision inspection.

Industries: Aerospace, automotive, food and beverage, plastics, rubber, general manufacturing

10 Intellect QMS - Most Adaptable Pick

Why We Chose It: Intellect QMS made our list due to its adaptability. Businesses across various sectors will appreciate its out-of-the-box solutions that align with industry best practices and are fully customizable. This ensures that the software can be tailored to fit seamlessly into any existing workflow.

A highlight of Intellect is its no-code compliance platform. This feature allows users without a technical background to modify or create apps, workflows, and reports. All this is a testament to Intellect’s commitment to user-friendly design and functionality. However, default workflows might not always align with specific industry standards, necessitating user configuration. Additionally, while the software’s customization is a strength, it can sometimes require a deeper understanding than some users might expect.

Industries: Chemical manufacturing, electronics, medical devices, automotive, energy

11 Ideagen - Best for Food and Beverage

Why We Chose It: Ideagen, formerly Qualtrax 1100, is a top choice for its specialized food and beverage edition, offering supply chain visibility and traceability. The software transforms food management systems by digitizing the tracking of raw materials and products. It also enhances data collection to pinpoint potential risks and weaknesses.

With features geared towards CAPA, quality control, and management reporting, it streamlines operations and prevents costly recalls. Additionally, Ideagen covers compliance management, document control, and audit management to ensure a comprehensive approach to food safety and quality.

12 DELMIA Apriso - Best for Global Operations

Why We Chose It: We went with DELMIA Apriso because it supports global manufacturing operations. As a Manufacturing Operations Management (MOM) and Manufacturing Execution System (MES) solution, it’s a good fit for large-scale manufacturers with complex operations. Overall, the system integrates quality management, material synchronization, and maintenance to ensure efficiency and accuracy in multinational production processes.

DELMIA Apriso’s strength lies in its ability to offer a unified, flexible, scalable, and secure foundation for digital transformation in manufacturing. It extends visibility beyond facility walls to the entire product supply network, enabling manufacturers to gain real-time, data-driven KPIs for better managing production lines, material flow, and cycle times. The software is enhanced with augmented reality solutions to guide operators in complex tasks and automate quality inspections, ensuring products are produced right the first time.

13 QT9 QMS - Best for Small Businesses

Why We Chose It: We picked QT9 QMS because it suits small and medium-sized businesses. This is due to its scalability and affordability. It offers a comprehensive suite of QMS features without the complexity or high costs typically associated with such systems. QT9 QMS simplifies compliance, audit management, and document control, making it accessible for smaller teams without extensive IT support.

The software’s modular design allows SMBs to choose and scale features according to their specific needs, avoiding unnecessary functionalities that larger enterprises might require. This tailored approach, combined with its intuitive design, makes QT9 QMS an excellent fit for SMBs seeking to enhance their quality management processes without overextending their resources.

Industries: Life sciences, manufacturing, pharmaceuticals, medical devices, food and beverage, plastics, aerospace

14 Qualcy - Transparent Pricing Model

Why We Chose It: We went with Qualcy because it has a transparent pricing model. Typically, pricing begins at approximately $799 per month. The minimum requirement for each plan is five users for a $495 subtotal, plus the $299 monthly fee for backup and maintenance support.

The basic plan from Qualcy includes 500 GB of storage, comprehensive reporting features, phone support, online training, and access to six key modules. This makes it a solid choice for small to mid-sized biomedical firms aiming to enhance their security measures and uphold ISO 13485 standards.

Industries: Medical devices, pharmaceutical, biomedical

15 Intelex - Best for EHSQ Management

Why We Chose It: Intelex made our list because of its comprehensive EHSQ (Environment, Health & Safety, and Quality) management capabilities. Its suite of applications covers document control, audits and inspections, and sustainability performance tracking. Intelex can also handle risk, compliance, and incident management.

Additionally, the platform supports organizations in managing their environmental impact by tracking emissions, waste management, water usage, and other sustainability indicators. Intelex’s data analysis and reporting capabilities help organizations track KPIs, identify trends, and make data-driven decisions to improve their EHSQ outcomes.

Industries: Aerospace, automotive, consumer goods, construction, food and beverage, healthcare, manufacturing, pharmaceuticals, oil and gas

16 QAD EQMS - Best Supplier Management

Why we chose it: We picked QAD EQMS, formerly CEBOS MQ1, for its proactive approach to supplier management. It’s one of the best QMS software because it weaves risk management into daily activities like evaluating suppliers and planning projects. Users can manage deviations, conduct self-assessment audits, and share critical documents and drawings with suppliers.

Additionally, QAD EQMS allows direct supplier involvement in managing their details and responding to corrective actions. This approach maintains high quality and compliance and fosters communication between companies and suppliers. Overall, QAD EQMS is tailored to meet industry standards like IATF, ISO, and MMOG/LE, making it versatile across automotive, life sciences, and more sectors.

What is Quality Management System (QMS) Software?

Quality management software, also known as QMS, offers a comprehensive tool kit to analyze business risks, set quality objectives on product development, implement workflows to achieve these standards, and audit the product lifecycle for optimal performance. This integrated approach allows your company to craft standard operating procedures (SOPs) to optimize business processes.

In particular, QMS helps businesses meet the regulatory requirements of ISO and FDA, in addition to compliance standards set by other government and industry-specific agencies.

Read more: What is a Quality Management System (QMS)? - ISO 9001 Processes

What is EQMS?

Enterprise quality management systems (EQMS) have a greater scope than generic QMS solutions. EQMS automates globalization by enhancing quality management practices across the supply chain. Many of these QMS products use the two terms interchangeably.

Read more: What is EQMS?

QMS Key Features

Quality management systems offer a wide variety of functionality. Modules often include the following core functions:

• Quality Control: Set objectives on quality processes related to cycle times, scrap/waste percentages, defect rates, measurement deviations, durability metrics, and more.
• Risk Management and Analysis: Create what-if scenarios to analyze potential costs related to quality exceptions reliably. Predict failure and service rates, as well as their financial implications.
• Workflow Management: Define all processes involved in manufacturing an end-product. Includes reminders, timers, and alerts. Determine corrective action assignments.
• Corrective Action/Preventative Action (CAPA): Includes task assignments, reporting, and monitoring to ensure the right response is implemented when quality has deviated outside pre-identified standards.
• Parts Non-conformance: Define the dimension parts are measured upon for non-conformance. Track a database of standardized parts metrics. May include more sophisticated monitoring controls that integrate with operational equipment.
• Customer Complaint Management: Assist service personnel in quickly resolving customer issues.
• Audits and Inspections: Define, schedule, and execute regular audits and inspections to ensure continuous improvement of business processes.
• Document Management: Coordinate the data management challenge, facilitate collaboration, and ensure easy access to important quality management documentation.
• Training Management: Ensure employees are trained and certified in key areas to meet compliance standards.
• Reporting and Business Intelligence: Reference key performance indicators and performance dashboards to turn quality management data into actionable business intelligence.

Industry-Specific Types of QMS Software

Industry-Agnostic QMS Software

Designed to be applicable across industries rather than tailored to a single sector’s specific needs. This software provides a framework for managing quality processes, compliance, and performance within an organization, regardless of its field of operation.

Medical QMS Software

Ensures that medical devices are designed and manufactured in compliance with regulations set by the U.S. Food and Drug Administration (FDA), the European Union’s Medical Device Regulation (MDR), and other international standards like ISO 13485.

Food and Beverage QMS Software

Ensures the safety and quality of food products from production to distribution. It facilitates compliance with HACCP (Hazard Analysis and Critical Control Points), FDA regulations (including FSMA - Food Safety Modernization Act), and GFSI (Global Food Safety Initiative) benchmarks.

Pharmaceutical QMS Software

Helps manage the quality of pharmaceutical products, including prescription drugs, over-the-counter medications, generics, vaccines, and biopharmaceuticals. It adheres to pharmaceutical regulations like FDA 21 CFR Part 210/211, Part 11 (for electronic records), and Good Manufacturing Practices (GMP).

Automotive QMS Software

Helps design, develop, test, and manufacture vehicles and their components. It enhances engine management, safety systems, infotainment, and autonomous driving technologies. Automotive QMS aligns with automotive quality standards like IATF 16949.

Aerospace QMS Software

Utilized in designing, simulating, testing, and maintaining aircraft and spacecraft, including commercial airplanes, military jets, drones, and satellites. It aids in managing complex systems and components, ensuring they meet rigorous safety and performance standards. Aerospace QMS ensures compliance with aerospace standards like AS9100.

Quality Management Software Benefits

QMS Benefit #1: Ensure Regulatory Compliance

Managing the product lifecycle for regulatory compliance is complex work. Manufacturers are often subject to an alphabet soup of regulatory standards (FDA, ISO 9001, Title 21 CFR Part 11, NERC, SSOP, HAACP, and more). Compliance can be required for permitting, an eligibility condition for bid consideration, or a business necessity to avoid penalties or other legal action. A quality system provides the monitoring and reporting tools to simplify the complexity.

Different types of manufacturers need to comply with different regulations. For instance, manufacturers of medical devices, food, cosmetics, and chemicals all have unique, strict rules to abide by. Selecting an industry-specific QMS system can help control compliance for specific industries.

QMS Benefit #2: Analyze and Reduce Risk

Every business faces risk: production errors, product defects, unexpected service work, and more pose a threat to the financial health of companies. Improved quality management offers a chance to mitigate these business risks and smooth out the variance in financial projections. QMS, with quality standards and audit management tools, provides an effective way to identify the root cause of any issues, allowing manufacturers to provide corrective action and enjoy higher-quality results.

Analysis tools can quantify the financial risks related to quality exceptions. Identifying the cost of quality management improvements versus the likely impact of reduced financial liability is one of the more challenging business issues facing manufacturers.

QMS Benefit #3: Increase Customer Satisfaction

Customer satisfaction is key to the success of every business model. Customers continually evaluate products for quality, reliability, and whether or not they do what they should do. Quality assurance modules provide ways to review products for defects before they get sent to retailers or consumers, allowing manufacturers to make corrections. Fewer defective products on the market mean happier customers.

Quality Standards Examples and Certifications

ISO standards include:

FDA certifications include:

Other common examples of quality standards include:

• API Q1/Q2: Standards specific to the oil and gas industry that are similar in nature to ISO 9001. API W2 has the explicit requirement for contingency planning. Both API Q1 and Q2 make the distinction between corrective and preventive action (something ISO 9001 does not)
• ASME: Highly focused on product specifications and work instructions. Little emphasis on standard QMS requirements such as nonconformities and corrective action
• API Design Stamps: Similar to ASME. Components have specific technical requirements to be met. Generally coupled with API Q1/Q2
• IATF 16949: Automotive quality management standard similar to ISO 9001 with additional requirements
• AS 9100: Aerospace quality management standard similar to ISO 9001 with additional requirements
• HACCP: Food safety preventative maintenance
• SQF: Food quality management

Non ISO Standards

• Statistical Process Control (SPC): Identify product quality issues and process variations to take corrective action before extensive issues occur and improve process performance. May pair well with a QMS but is better used to report on the output of the production process.
• Production Design Lifecycle System (PDLC): Mainly used for showing verification and validation of product design requirements. Focus on the interaction between suppliers, engineering, and test data. Includes production part approval processes (PPaP).

How Much Does QMS Software Cost?

QMS software ranges from $50 to $2,000 per user per month. Pricing of quality management systems depends on several factors:

• Number of users
• Required functionality
• Additional integrations

Another variable to consider is whether you want an on-premise or cloud-based system. Generally, on-premise software will have a one-time perpetual licensing fee, while a cloud platform will be part of a monthly or annual subscription. The one-time fee and setup often result in a higher cost of entry, while SaaS QMS can be more expensive over time.

Integrating QMS and ERP

Quality management software incorporates information from across the enterprise. QMS systems are often found within larger ERP software.

Because QMS systems typically operate best when they are taking a holistic approach to the enterprise challenge of optimizing quality, companies may need to manage integrations with other information systems, such as:

• Supply chain management systems manage the provisioning of goods from suppliers to the customer. Relaying information regarding quality issues stemming from certain suppliers is an essential piece of the quality management puzzle.
• Customer relationship management software programs provide a coordinated approach to capturing customer-specific information. Order histories and other customer interactions are logged into CRM programs. The ability to flow quality issue information from CRM software to QMS programs is essential. It can assist in ensuring that quality issues addressed post-sale are being addressed in terms of service work and process improvement.
• Material resource planning and production scheduling software manages the materials required for production and the processes that go into the manufacturing operations. Importing quality-related information from the QMS to the MRP system will help create more accurate manufacturing plans and forecasts.

Further Reading

• What is a Quality Management Process?
• What are Quality Standards?
• Quality Control vs Assurance
• Quality Compliance vs Management
• 5 Indispensable Quality Management Tools