Best Quality Management Systems Software
Whether you manufacture medical devices or process food and beverages, QMS helps you meet standards like ISO 9001 and FDA regulations. We’ve reviewed the top platforms, focusing on key features like lot traceability, industry-specific compliance, and easy-to-use audit trails to keep your operations running smoothly.
- Provides a centralized repository for information
- Gap analysis streamlines audit preparation
- Strong reporting system for data visualization
- Responsive customer support
- Intuitive, user-friendly interface
- Automated document routing and revision control
- Flexible deployment options with access on all devices.
- Has 25+ pre-installed modules for advanced functionality.
- Full validation included for life sciences companies.
QMS software helps assess, maintain, and enhance product and service quality. It often specifically helps with industry compliance standards (e.g., ISO 9001) and regulations. Using our advanced review methodology, our team tested most of the popular systems on the market and ranked them below.
- Ideagen: Best for Food and Beverage
- Greenlight Guru: Best for Medical Device Industry
- QT9 QMS: Best for Small Businesses
- Qualio: Best for Life Sciences Sector
- EtQ Reliance: Best for Mid-Sized Companies
- Qualcy: Transparent Pricing Model
- DELMIA Apriso: Best for Global Operations
- MasterControl Qx: Best Product Lifecycle Automation
- Unifize: Best for Collaboration
- SmartSolve eQMS: Best Postmarket Surveillance
Ideagen - Best for Food and Beverage
Ideagen Quality Management, formerly Qualtrax 1100, offers a dedicated food and beverage edition that simplifies quality control through its supplier management module. This helps you stay on top of regulations like Hazard Analysis and Critical Control Points (HACCP) and the Food Safety Modernization Act (FSMA) by managing documents, assessing risk, and tracking compliance.
With the Supplier Overview dashboard, you can see a quick snapshot of all pending and completed tasks, including quality checks and self-assessment questionnaires (SAQs). SAQs allow suppliers to self-assess based on criteria you customize, such as compliance with ingredient quality standards, allergen control, and traceability practices. If a supplier falls short, you can raise non-conformances and track incidents with a full audit trail, letting you proactively manage quality issues and sidestep supply chain disruptions.
Ideagen also lets you approve or reject documents submitted by suppliers, including raw material specifications and allergen validation reports. It also automatically tracks expired documents and certifications, which helps you avoid using non-compliant ingredients. Additionally, Ideagen’s recipe management table gives you detailed control over supplier-provided recipes, letting you quickly review raw material codes and ingredient quantities.
The supplier management module also includes a finished products tool. Here, you can manage in-progress items, like combining approved raw materials to calculate serving sizes and nutritional values such as fat and carbohydrates. This helps ensure ingredients from you suppliers meet your requirements and nutritional labeling standards. That way, you can ensure quality throughout your production process and avoid using non-compliant materials, making it easier to meet your customers’ expectations.
Greenlight Guru - Best for Medical Device Industry
Greenlight Guru is 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. It’s easy 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.
QT9 QMS - Best for Small Businesses
QT9 QMS suits smaller companies in manufacturing, plastics, life sciences, and food and beverage 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.
Qualio - Best for Life Sciences Sector
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.
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.
EtQ Reliance - Best for Mid-Sized Companies
EtQ Reliance is particularly suited for medium to large enterprises. It offers wide-ranging utility in highly regulated industries such as life sciences, medical devices, pharmaceuticals, and food and beverage.
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 quality management.
Qualcy - Transparent Pricing Model
Qualcy has a transparent pricing model, beginning 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.
DELMIA Apriso - Best for Global Operations
DELMIA Apriso 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.
MasterControl Qx - Best Product Lifecycle Automation
MasterControl Qx can 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
Unifize - Best for Collaboration
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
SmartSolve eQMS - Best Postmarket Surveillance
SmartSolve 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.
uniPoint
uniPoint 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
Intelex
Intelex offers 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
QAD EQMS
QAD EQMS, formerly CEBOS MQ1, provides a 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.
DELMIAworks
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
Intellect QMS
Intellect QMS offers adaptability in quality management. 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
TrackWise
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
What is Quality Management System (QMS) Software?
Quality management software, also known as QMS, offers a comprehensive toolkit to analyze business risks, set quality objectives for 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?
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 and 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 from 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
Industry-Agnostic
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
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
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
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
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
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.
Benefits
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.
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. One of the more challenging business issues facing manufacturers is identifying the cost of quality management improvements versus the likely impact of reduced financial liability.
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. Quality assurance modules provide ways to review products for defects before they are sent to retailers or consumers, allowing manufacturers to make corrections. Fewer defective products on the market mean happier customers.
Quality Standards Examples
ISO standards include:
| ISO Standard | Meaning |
|---|---|
| ISO 9001 | Sets out the criteria for a quality management system and is the only standard in the family that can be certified (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity |
| ISO 13485 | Similar to ISO 9001 but for medical devices. Has a specific requirement for software validation and requires validation reports to verify for the auditor that it will work as intended. Includes requirement for CFR 21 specific electronic signatures |
| ISO 50001 | Energy management standard for addressing the energy consumption and use of an organization |
| ISO 27001 | Information security, similar to ISO 9001 but with a change in focus to data security and integrity vs product quality |
| ISO 45001 | Health and safety, similar to ISO 9001 but with a change in focus to employee safety vs product quality |
| ISO 14001 | Health and safety, similar to ISO 9001 but with a change in focus to environment concerns vs product quality |
| ISO 17025 | Laboratory testing and calibration |
FDA certifications include:
| FDA | Meaning |
|---|---|
| FDA 21 CFR Part 11 | Electronic records and electronic signatures |
| FDA 21 CFR Part 211 | Drug and pharmaceutical manufacturing |
| FDA 21 CFR Part 820 | Medical device manufacturing and distribution |
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).
Pricing
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 has a one-time perpetual licensing fee, while a cloud platform is 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.
