Best Medical Quality Management Systems for Windows
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Compare the Top Medical Quality Management Systems for Windows as of January 2026
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What are Medical Quality Management Systems for Windows?
Medical Quality Management Systems software is a type of software that helps to manage quality assurance processes for medical devices, pharma products, and biotech. It typically includes functionalities such as audit management, document control, corrective action and preventive management (CAPA), risk management and process improvement tracking. The software helps organizations minimize the risks associated with non-compliance by allowing them to effectively manage their quality management systems in line with industry regulations. These systems help ensure product safety and efficacy for medical products, enabling companies to quickly identify any potential issues related to product development or manufacturing processes. They also provide detailed records of all activities related to quality control and compliance requirements, which can be used for continued improvement of processes over time. Compare and read user reviews of the best Medical Quality Management Systems for Windows currently available using the table below. This list is updated regularly.
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1
Total Lean Management (TLM) Software
Lean & Mean Business Systems
Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals. TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types. Core modules include: • Audits • Contact Manager (CRM) • CAPA • Customer Feedback • Document Management • Electronic Forms • Employees • Employee Feedback • Equipment Calibration • Evaluations • FMEA • Inspections • Inventory/parts • Library • Meetings/Reviews • Metrics • Projects • Purchase Orders • Quality Record Mgt • Rejected Materials • Risk & Opportunities • Sales Orders • Strategic Planning • Surveys • Tasks/Events • Training • Work OrdersStarting Price: $45/user/month -
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qmsWrapper
qmsWrapper
qmsWrapper is an interconnected Quality Management Software for startups and small businesses. It helps all companies that want to increase productivity with ISO 9001:2015 and MedDev creators to easily achieve and manage ISO 13485:2016 and 21 CFR 820. At qmsWrapper, we cater to each industry’s unique quality management needs with tailored features: Compliance Made Easy: Adhere to standards like ISO 13485 and ISO 9001 effortlessly, maintaining a robust QMS. Risk Management: Simplify risk assessment with ISO 14971-compliant tools, effectively mitigating risks. Document Control: Intuitively manage documents for enhanced traceability and version control. Cloud-Based Accessibility: Access your QMS anytime, anywhere. Electronic QMS: Embrace efficiency with digitized QMS for faster approvals and real-time updates. Audit Management: Prepare for audits confidently with scheduling, tracking, and reporting tools.Starting Price: $250/month/10users -
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Qualityze EQMS Suite
Qualityze
Qualityze is a leading provider of enterprise quality management solutions, utilizing the Salesforce.com Technology Platform to build our EQMS Software solutions. Our team is 100% devoted to quality processes, compliance, and regulatory guidelines to address our customers' business environments. We do not distract ourselves with custom work or quality concerns. The idea of helping our customers create a culture of quality is not a new concept, but the way we developed our application, Quality Management Software, based on making it easy to use, intuitive, and inclusive. Therefore, the entire organization is involved in quality, not because they are told they should, but because it's easy, fun, and has a logical flow. We strive to optimize quality with excellence through our exclusive range of smarter quality management software solutions.Starting Price: $30/User/Month -
4
MasterControl
MasterControl
Bringing breakthrough products to market in highly regulated industries can feel like an endless series of trade-offs. MasterControl's software simplifies GxP workflows so you never have to sacrifice quality for cost or innovation for regulation. Complete and connected meets fast and flexible. From quality event management to document control and integrated training - MasterControl Quality Excellence transforms your quality data and processes into a competitive advantage. Modernizing your manufacturing operations starts with modern software. From work orders to work instructions and production records (EBR or eDHR) to logbooks, MasterControl Manufacturing Excellence is the simplest way to digitalize manufacturing.Starting Price: $25,000 / 1st year -
5
ACE Essentials
PSC Software
Reduce risk with ACE Essentials, the pre-validated Electronic Quality Management System (EQMS) software created for all highly regulated industries. ACE Essentials comes equipped with 10 workflows built in and all the necessary Standard Operating Procedures and Policies, resulting in a fully compliant quality management system from the beginning. Understand the risks associated with your assets with ACE Essentials features including a full audit trail tracking every single action in the system. Pre-Configured Workflows. Pre-Configured Event Management (Due Dates, Scheduling and Reminders). Pre-Configured Permission-Based Security. Full Documentation Pre-Configured. 50+ Documents. Multiple Site Capability. Free Upgrades Throughout the Life of the Product. Pre-Configured Tasks List. No Validation Time. Pre-Configured In-System Notifications. Pre-Configured Email NotificationsStarting Price: $500 one-time payment -
6
QT9 QMS
QT9 Software
Struggling with complex compliance requirements or disconnected quality systems? QT9 QMS eliminates these challenges with one integrated, fully validated platform that scales with your business. Designed for life sciences, aerospace, and manufacturing, QT9 offers cloud or secure on-premise deployment to meet your needs. Stay audit-ready automatically with built-in FDA, ISO, and EU MDR compliance while reducing manual work by up to 70%. With 28+ modules included—like document control, CAPA, training, and supplier management—QT9 deploys fast without costly customization. Backed by ISO 27001 certification, unlimited support, and 20+ years of proven success, QT9 helps 1,100+ organizations accelerate compliance, improve visibility, and simplify quality management. Start your free trial or book a personalized demo today.Starting Price: $10,000/year -
7
Dot Compliance QMS
QMS for Life Sciences
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements. Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE! Processes included: ▶ Document Management ▶ Training Management ▶ Quality Event Management ▶ CAPA Management ▶ Change Management ▶ Complaint Management ▶ Audit Management ▶ Supplier Quality Management ▶ Risk Management ▶ Design Control ▶ Deviations/Non-conformances ✔ Seamless Install ✔ Cost Effective ✔ One-Stop-ShopStarting Price: $10,000 / Annually -
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SimplerQMS
SimplerQMS
SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry. This comprehensive QMS platform helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, ICH Q10, and others. The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience. SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.Starting Price: $13,750/year -
9
Orcanos ALM and QMS
Orcanos
Deliver products on time and on budget with Orcanos, an integrated software for ALM (Design Control) and quality management (QMS). An affordable cloud solution, Orcanos supports Requirements Management, Test Management, Document Control, Risk Management, and Quality Management procedures, on a single repository. Orcanos also features dashboards and real-time alerts, to help businesses keep track on their ongoing projects and gain real-time visibity on their progress. Orcanos e-DMS is an all-in-one document control software system that has been designed to allow end users to create, trace, search, archive and approve all documentation that is related to every stage of a medical device product launch. The e-DMS ensures that documents relating to the planning, design, development, manufacturing and service of a particular product can be quickly accessed, increasing the effectiveness of quality processes and reducing the time to market.Starting Price: $69.00/month/user -
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Paradigm 3
Interax Group
Paradigm 3 is a web and desktop-based platform designed to aid businesses in compliance management in regards to Document Control, CAPA Compliance, and Competency Tracking and Training. The software offers tools such as an event manager for incident investigations and customer complaints, tasks delivered by e-mail, audit preparations, among others. Some of the industries that benefit from Paradigm 3 are Healthcare, Manufacturing, Test Labs, and Service Industries. With Paradigm 3 it is no longer necessary to buy endless add on modules to manage all your compliance needs. Our system is made up of 4 modules with over 50 standard forms to meet all of your requirements for Quality, Safety and Environmental and by utilizing our form designer you can create new forms or redesign the ones supplied to ensure they exactly meet your needs.Starting Price: $1000.00/one-time -
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Matrix Requirements
Matrix Requirements
For companies looking to accelerate development of their innovative medical device technologies, our Application Lifecycle Management and Quality Management Systems (eQMS) are easy-to-use, flexible, all-in-one software solutions designed to facilitate collaboration of employees on design control, and quality management to streamline medical device design. Innovate faster with a flexible item-based approach to documentation designed to control even the most complex SxMD (Software as/in a Medical Device) product design. Enhance quality management and ensure compliance with full traceability from design input to output with a purpose-built software platform that enables a collaborative quality culture across all teams. Ensure frictionless alignment between platforms with native integrations for Jira, GitLab, GitHub, Azure DevOps and more.Starting Price: $500 per month -
12
Harrington Quality Management Software (HQMS)
Harrington Group International
HQMS' applications include Document Control, Audits, Corrective Action, Calibration, Training, Material Nonconformance, PPAP, Project Management, Risk Management and the HQMS Supplier Portal. In business since 1991 – trustworthy source with SME Experts in Sales and Support will help with Business Case, Flexibility (on-premise or hosted, CapEx and Opex pricing models) with Support and Training & deployment planning that provides rapid learning curve with implementation guides. Secure deployment – including Single Sign On (SSO). Configuration and personalization features with customization if needed. HQMS is used cross several markets, including manufacturing (Aerospace and Defense, Automotive, Consumer Products, Medical Device, Food, Energy, and more), healthcare, retail, non-profits, and government.Starting Price: $500/month -
13
IMSXpress ISO 9001
IMSXpress
IMSXpress ISO 9001 is a document control and quality system management software. The IMSXpress client application can be installed directly on user computers, or on a Windows server and then be distributed to users by remote desktop services as a remote application. The database is an MS SQL database. It can be installed on any MS SQL Server 2014 or higher and be accessed by the IMSXpress application over any type of network. You can set up your own remote access, use our cloud-based data hosting service, or get the online subscription package. Fully automated training system with self-training, integrated document training, job descriptions, and more. Use for document, engineering, and process changes. Make fillable PDF form templates, fill the forms with data, and create records. Use for scheduling and administrating maintenance, and for managing spare parts inventory. Manage complaints, non-conformities, risk management, audit findings, and more.Starting Price: $160 per month -
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uniPoint Quality Management Software
uniPoint Software
uniPoint's Quality Management Software is a modular on-premise quality management software. Quality Management Software can integrate with other ERP systems with ease. Quality Management Software is suitable for manufacturers of any kind of product in any manufacturing mode. With Quality Management Software, users can manage processes such as document control, equipment management, non-conformances, corrective/prevantative actions, and more.Starting Price: $6000.00/one-time -
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ARMATURE Fabric
ARMATURE
With ARMATURE Fabric™ you can manage your accreditation, certification, credentialing, audit, quality, and compliance activities within a single platform. Our software enables you to save time, operate more effectively and securely, and better serve your stakeholder communities. Whether you are managing institutional, programmatic, or specialized accreditation programs; certifying individuals, products, or organizations; conducting audits or assessments; or resolving non-conformances or other issues, ARMATURE Fabric can make it easier and more efficient for you and your stakeholders. Our secure, cloud-based software allows you to collect data in multiple ways (through online applications, audits, assessments, self-evaluations, inspections, forms, and surveys); manage your accreditation, certification, audit, and compliance workflows; capture and manage documents and artifacts, identify and remediate issues; generate reports; and spot new trends. -
16
Ennov Doc
Ennov
Unified Access to All Documents - Consolidates documents & processes in a unified document repository that can be used for Quality, Regulatory, R&D and more. - Metadata-based document model to adapt to your company’s organizational needs. - Configurable without any IT skills. - Scalable & secure: manage large volumes of documents. Improved Productivity and Efficiency - Intuitive user interface - Efficient search capabilities - User-centric design and connectivity to Microsoft Office 365 and Google Drive - PDF viewer to allow instant access to documents without MS Office or Acrobat - Versioning - Complete document cycle management Supports wide EDM needs - Quality, regulatory, cR&D, legal, commercial - CFR21 part 11 compliant - Document archival included - Seamless integration with Ennov Process (BPMS) & Dossier (eCTD publishing) - Advanced live reporting and dashboarding - Configurable without IT skills (including dashboards) - Suitable for regulated industries -
17
QEdge
Sarjen Systems Pvt Ltd
Sarjen's QEdge stands as a robust, risk-based enterprise Quality Management System, meticulously designed for the pharmaceutical manufacturing and broader life sciences industries. This comprehensive solution adeptly streamlines crucial quality processes, including Change Control, Deviation management, CAPA, efficient Document Management, and automated Training with SCORM-based eLearning. QEdge ensures stringent and full compliance with major regulatory standards such as FDA, EU-GMP, and ICH guidelines. By fostering operational excellence, maintaining impeccable data integrity, and guaranteeing audit-readiness in complex GxP environments, QEdge significantly enhances overall quality management. It provides essential process control and simplified vendor qualification, driving efficiency and superior quality across all operations. -
18
Nova-QMS
Novatek International
Maintaining consistent product quality and quality processes can be challenging in today’s pharmaceutical manufacturing environments. Regulated industries such as the Pharmaceutical, Biotech and Life Sciences are required to maintain Good Manufacturing Practices (GMP) to meet regulatory requirements. Not only do you need to meet GMP requirements you must also be able to prove this. Using paper-based forms, disconnected systems, or manual processes to manage, track and report on quality issues and actions does not provide effective solutions for implementing harmonized, integrated quality management processes, which follow industry best practices. -
19
QCBD
CAMA Software
Quality Collaboration By Design (QCBD) is a fully integrated quality management software solution designed specifically for manufacturing businesses. This affordable, Windows-based application reduces the cost of achieving and/or maintaining compliance with quality management standards such as ISO 13485, ISO 9001, TS 16949, AS9100, and SQF 2000 / ISO 22000. QCBD by CAMA Software offers a host of modules for training management, supplier management, process deviations, document control, equipment management, and more. -
20
NWA Quality Analyst
Northwest Analytics
NWA Quality Analyst® is an award winning SPC charting and analysis software solution providing the best combination of power, flexibility, and ease-of-use of any SPC software available. It enables a wide range of users to graphically analyze process behavior and judge the impact of process improvement decisions with minimal training in statistical techniques. -
21
ComplianceQuest
ComplianceQuest
Fastest growing Enterprise Quality, Health and Safety Management System (QHSE) natively built and run on the Salesforce platform. Unified QHSE solutions, which combine EQMS and EHS, help our customers of all sizes deliver quality products and services in the safest, most sustainable way by mitigating risk, problems, and inefficiencies while protecting customers, employees, suppliers and brand. Every organization – irrespective of its industry, geography or size – involves an interaction of activities and processes with the environment. These activities may have an adverse or favorable impact on the environment depending on the type of activity being carried out. Our Environment Management solution has been designed to minimize and mitigate these adverse impacts on environment, to such an extent that our already depleting biodiversity is protected, and nurture an ecosystem where all living organisms coexist sustainably.Starting Price: $30 per user per month -
22
SoftExpert EQM
SoftExpert
SoftExpert EQM is the most comprehensive enterprise quality management software (EQMS). It helps companies to achieve and maintain ISO 9001 certification through automated, highly interactive quality processes tailored to an organization’s specific products, operations and business practices. As a modular and scalable solution platform, SoftExpert Quality Management Software seamlessly integrates all key quality initiatives, including process mapping, documented information (SOP – standard operating procedures, work instructions and records), non-conformance reports (NCR/NCMR), corrective/preventive actions (CAPA), quality indicators (KPIs). The solution also manages supplier relations, customer complaints, quality audits, competence and training, quality risks and controls, quality inspection and statistical process control, increasing QMS agility and robustness. -
23
AssurX
AssurX
The AssurX platform is a versatile enterprise quality management system (EQMS) and regulatory compliance management platform. AssurX allows enterprises of any size or complexity to create a system that reliably communicates and coordinates quality and compliance information, documentation, and activities across the enterprise. AssurX allows regulated businesses to quickly identify and control risk exposure and avoid quality or noncompliance problems while improving workflow. AssurX QMS software is highly configurable to fit any established or dynamic business requirements. The system creates an electronic workflow of tasks, alerts, escalations, and approvals that can be automated to the desired level, mapping precisely to real-world operations. Begin with just the solutions and functionality you need now, then implement what you like whenever you’re ready. No other system is easier to deploy, configure, and modify. -
24
FORM OpX
FORM.com
Compliance software that drives operations. Improve safety and increase accuracy with the top mobile audit and inspection platform for teams trusted by Walmart, Wendy’s, and Fannie Mae. Upgrade your paper, Excel, and digital processes to the #1 field management platform for teams. FORM OpX combines advanced data collection and configurable workflows with powerful operational insights to boost compliance in real-time. Configure audits, inspections, and workflows to ensure teams consistently follow procedures and meet regulatory obligations. Capture data instantly with digital forms that guide teams to the right action. Configure automated alerts and escalations to trigger corrective action as soon as issues arise. Save time and money with customizable workflows that improve processes and increase compliance — everywhere. -
25
BabtecQ
Babtec Informationssysteme
Quality management software. We manufacture and offer QM solutions for all quality tasks – as we have done for 25 years. As quality specialists, we have developed an all-round solution for quality management with our modular software BabtecQ. In addition, we offer Babtec Qube, a cloud-based platform with which you can interconnect with your suppliers and customers to edit your quality tasks. Our products allow you to depict the whole range of quality processes, both internal and across companies – for quality you will love to share. Would you like to refresh your knowledge about quality management? Then you have come to the right place! On our knowledge pages you can find out, for example, what complaint management or 8D report are all about. The System FMEA (also termed a system analysis) is a subsection of the FMEA (Failure Mode and Effects Analysis). It is intended to investigate an entire system and check whether all of the individual components within it work together correctly. -
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DELMIAworks
Dassault Systemes
Combine manufacturing, MES, supply chain, and ERP software to optimize your shop floor. Learn how DELMIAworks (formerly IQMS) can help increase visibility into every aspect of your manufacturing operation and solve your most trying production challenges. Prevent unnecessary downtime, while increasing manufacturing efficiency, quality, and profit margins. Improve decision making with real-time access to data across the entire supply chain. A single system for all ERP, manufacturing, MES, and supply chain requirements. Lower your overall cost of investment and maintenance by automating your business. Our easy-to-use solution can help you double plant output, eliminate human errors, and increase the efficiency of your production planning process. Manage, track and monitor the complete production process to eliminate unplanned downtime and increase throughput. OEE charts and graphs are dynamically updated with performance and quality data in real-time. -
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SpineNEXTGEN
Spine Software Systems
SpineNEXTGEN is the one-step GST compliant ERP solution for pharma companies. Built with a whole host of cutting edge features, including cost, sales, and purchase management, SpineNEXTGEN is the go-to ERP software for pharmaceutical industry. There has been a lack of a competitive ERP software system in pharmaceutical industries for quite some time now. SpineNEXTGEN brings to you a method to bridge this gap, providing the best pharma ERP solutions for companies looking to manage all aspects of their businesses in one place. If you are looking for the best ERP software for manufacturing and management in the pharma industry, then look no further than SpineNEXTGEN! -
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ValGenesis
ValGenesis
ValGenesis's VLMS is chock-full of features and functions that are designed to significantly improve traditional validation processes. Our system provides a holistic view of the entire validation process, comprehensive validation lifecycle management functionality, and the ability to integrate with existing systems. With paperless validation software, workflows are automated, compliance requirements are instantiated in automated processes, and electronic signatures are performed via instantaneous routing along with automatic notifications. Metrics, dashboards, and reporting are immediately available. Requests during audits and inspections are fulfilled with minimal effort. Standards are implemented and consistency is therefore attained as it pertains to requirements management, testing methodology, and risk management. -
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DataMetrics
DATAMYTE
No matter what product you manufacture, DataMetrics can provide your operators, engineers, quality team, and managers with the detailed, real-time SPC data, analytics and reporting, they need to assess current processes and take a proactive approach to maintain or improve product quality, meet production goals, reduce costs arounds scrap and rework, comply with OEM or industry standards. A genius interface to your entire manufacturing floor to support universal data collection across manual, semi-automated, automated and portable data acquisition; giving you the ability to capture ALL of your quality data into one centralized repository or database and report on this data. Eliminate data silos while consolidating data from hundreds of gages, sensors, CMM, PLC; essentially any type of open interface. Compliant with OPC-UA, DataMetrics is a solution backed by stringent access control and advanced security. -
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Ennov Quality Suite
Ennov
Ennov Quality Suite. A comprehensive QMS to improve efficiency and ensure compliance. Ennov Quality Suite Ennov’s Quality suite combines the power and flexibility of Ennov Doc, Ennov QMS, Ennov Report and Ennov Training to create a quality management solution that not only improves operational efficiency but also ensures compliance with industry standards such as 21 CFR Part 11, GxP and ISO. Ennov Quality provides a predefined inventory of quality documentation, processes and workflows that are based on accepted industry standards and best demonstrated practices. This allows Ennov Quality customers to get their system into production quickly and start realizing their return on investment. Ennov Quality, like all Ennov solutions is very easy to configure and requires no IT skills. An intuitive and unified content and information management platform to support and enrich the entire Life Sciences product life cycle. Our comprehensive QMS improves operational efficiency
