List of the Top 25 Medical Quality Management Systems for Windows in 2025

Optimize every phase of the development lifecycle with a versatile solution tailored for SxMD, allowing for effective management of design controls that span from initial requirements to compliance, all while ensuring comprehensive traceability to reduce risk. Accelerate innovation through a flexible item-based documentation strategy that caters to the intricate demands of even the most sophisticated SxMD products. Improve quality management by maintaining full traceability from design inputs to outputs with a specialized software platform that fosters collaborative quality practices across all departments. Take command of the shifting landscape of design, quality, and regulatory criteria while promoting team independence, ensuring your product reaches the market more swiftly. Achieve seamless integration across platforms with built-in connections to Jira, GitLab, GitHub, Azure DevOps, and more, while also utilizing our REST API to link all your essential tools effortlessly. This comprehensive approach empowers teams to not only adapt but thrive in a fast-paced development environment.

TLM QMS Software is an advanced and reliable platform for quality, risk, and material management that meets validation and 21 CFR Part 11 compliance standards. This innovative, comprehensive quality management system is designed for customization, allowing seamless integration with online CRM solutions, QuickBooks, or ERP systems. Total Lean Management (TLM) QMS Software aims to provide an economical and highly cohesive environment that is adaptable and continuously evolving, enabling the incorporation of specialized systems as necessary to develop a digital business ecosystem tailored to your organization’s workflow requirements. This flexibility ensures that the software can grow alongside your business, responding effectively to changing needs over time.

qmsWrapper is a comprehensive Quality Management Software designed specifically for small businesses and startups. This tool is ideal for organizations aiming to boost efficiency by adhering to ISO 9001:2015 standards, as well as for MedDev creators seeking to seamlessly navigate the requirements of ISO 13485:2016 and 21 CFR 820. It is particularly beneficial for businesses that require assistance in establishing and utilizing an effective, validated Quality Management System. Additionally, it serves companies looking to streamline their quality management processes by transitioning from traditional paper-based methods to automated solutions.

The Qualityze EQMS Suite represents an innovative approach to Enterprise Quality Management Software, tailored for organizations aiming to streamline their quality processes, meet customer demands, and adhere to compliance standards. This software empowers businesses to tackle operational hurdles, thereby enhancing their performance in quality, safety, and reliability. With a variety of pre-defined templates available for controlled documents, audit checklists, regulatory forms, and material compliance reports, it offers comprehensive support. The suite consists of 14 interconnected modules that facilitate a complete quality management system accessible from any location. Built on the robust Salesforce.com technology platform, these modules include Nonconformance Management, CAPA Management, Document Management, Change Management, Audit Management, Training Management, Supplier Quality Management, Inspection Management, Customer Complaints Management, Material Compliance Management, Forms Management, Permit Management, Calibration Management, Maintenance Management, and Field Safety Management. By leveraging our Quality Management solutions, organizations can foster a culture of quality and drive continuous improvements, effectively addressing and mitigating potential quality challenges before they escalate. This proactive approach not only improves overall operational efficiency but also solidifies customer trust and satisfaction.

ACE Essentials serves as an Electronic Quality Management System Software (EQMS) that has been pre-validated for use in industries that are highly regulated. This comprehensive system encompasses ten distinct workflows alongside all necessary Standard Operating Procedures (SOPs) and Policies, guaranteeing that your quality management system is compliant right from the outset. Furthermore, ACE Essentials boasts a complete audit trail that meticulously tracks all actions taken within the system, helping you assess the risks linked to your assets. Key features of ACE Essentials include: - Pre-Configured Workflows - Pre-Configured Event Management (such as Due Dates, Scheduling, and Reminders) - Pre-Configured Permission-Based Security - Pre-Configured Full Documentation comprising over 50 documents - Capability for Multiple Sites - Free Upgrades for the Lifetime of the Product - Pre-Configured Task Lists - No Validation Period Required - Pre-Configured In-System Notifications - Pre-Configured Email Notifications This robust system is designed to streamline quality management practices, ensuring organizations can efficiently meet regulatory demands while focusing on their core operations.

Bringing innovative products to market in heavily regulated sectors often feels like an unending series of compromises. However, MasterControl's GxP software streamlines workflows, ensuring that you don't have to sacrifice quality for cost or innovation in the face of regulation. With a perfect blend of completeness and connectivity, combined with a focus on flexibility and speed, MasterControl Quality Excellence turns quality data and processes into a significant competitive advantage. The journey toward modernizing your manufacturing operations begins with advanced software solutions. MasterControl Manufacturing Excellence simplifies the digital transformation of manufacturing, covering everything from work orders and production records to logbooks and work instructions, making it the most straightforward approach to digitizing your manufacturing processes.

Streamline your quality processes with QT9's comprehensive cloud-based Quality Management System (QMS) Software Suite. Designed for ease of use, QT9 QMS features over 25 modules that offer unlimited scalability to meet your needs. Enhance your ISO and FDA compliance efforts with automated email alerts, task lists, and FDA 21 CFR Part 11 compliant electronic approvals. QT9 QMS empowers organizations in the Life Sciences, Biotechnology, Medical Device Manufacturing, and Pharmaceutical sectors to achieve digital transformation in their operations. Stay informed with real-time status updates and instantly visualize your quality metrics. The software includes essential features such as document control, revision management, corrective actions (CAPAs), and nonconformance tracking, among others. Additionally, it facilitates streamlined product releases with modules for Deviation Management, Engineering Change Orders, Failure Mode and Effects Analysis (FMEA), and Inspection Management. Transition to a paperless environment and automate your labor-intensive tasks effortlessly. QT9 QMS is ready for immediate use, allowing you to get started quickly. Experience it firsthand by signing up for a free product tour or beginning your free trial today at QT9qms.com. Embrace the future of quality management and elevate your organization's efficiency.

Dot Compliance has introduced the first ready-to-use Quality Management Solution integrated with the Salesforce.com platform. This innovative solution encompasses a comprehensive array of pre-configured eQMS and compliance processes, allowing clients to implement it swiftly and affordably. Included in the Dot Compliance offerings are complete project validation services alongside product validation packages. Their solution stands out as the most economical option for quality and compliance management in the industry, empowering users to deploy adaptable and scalable solutions without delay. Key quality processes such as Document Management, Training Management, CAPA, Audits, Customer Complaints, Change Management, and Supplier Quality can be automated effortlessly. Furthermore, the solution is designed to be fully configurable and supports seamless integration, which makes it easy for customers to tailor the system to meet their unique specifications. By prioritizing user needs, Dot Compliance ensures a smooth transition and effective management of quality across various operations.

SimplerQMS provides a cloud-centric Quality Management Software tailored specifically for the Life Science sector. This innovative platform ensures adherence to an array of regulatory standards, 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, and ICH Q10, among others, and is fully validated under GAMP5 guidelines. The software encompasses a comprehensive suite of Life Science QMS modules, including Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, and Quality KPIs, among additional functionalities. Moreover, SimplerQMS seamlessly integrates with Microsoft Office, enabling users to manage documents within familiar applications like Word, PowerPoint, and Excel. In summary, SimplerQMS not only streamlines operations through efficient, paperless workflows but also ensures that organizations can meet the stringent compliance mandates essential in the Life Science industry. Furthermore, its user-friendly interface and robust capabilities make it an indispensable tool for companies looking to enhance their quality management processes.

Orcanos provides a robust software solution designed for Application Lifecycle Management (ALM) and Quality Management Systems (QMS), ensuring that products are delivered on time and within budget. This efficient cloud-based platform integrates functionalities such as Requirements Management, Test Management, Document Control, Risk Management, and Quality Management into a single repository. Users benefit from intuitive dashboards and real-time alerts that enhance project monitoring and visibility throughout the development process. The Orcanos e-DMS serves as a comprehensive document management system, enabling users to create, track, search, archive, and approve documentation critical to each stage of medical device launch. By streamlining access to essential documents related to planning, design, development, manufacturing, and servicing, the e-DMS improves the efficiency of quality processes and significantly reduces time to market. Furthermore, this optimized workflow empowers organizations to prioritize innovation and adhere to regulatory standards while maintaining high levels of productivity, ultimately fostering a culture of continuous improvement.

Paradigm 3 is an all-encompassing platform that caters to both web and desktop users, specifically designed to support businesses in managing compliance with a strong emphasis on Document Control, CAPA Compliance, and Competency Tracking and Training. The software boasts a plethora of features, such as an event manager to oversee incident investigations and customer complaints, notifications for tasks delivered via email, and audit preparation tools, among various others. Various sectors, including Healthcare, Manufacturing, Test Labs, and Service Industries, find significant advantages in utilizing the capabilities offered by Paradigm 3. This cutting-edge solution allows organizations to reduce reliance on multiple additional modules necessary for meeting compliance standards. The platform comprises four main modules that include more than 50 standard forms aimed at covering all facets of Quality, Safety, and Environmental management. Additionally, the form designer functionality grants users the ability to craft personalized forms or alter existing ones, ensuring that every unique requirement is met with precision. This adaptability in form customization not only elevates the platform's effectiveness but also establishes it as an essential resource for businesses committed to achieving compliance excellence. Ultimately, Paradigm 3 serves as a vital tool in navigating the complexities of compliance management.

HQMS offers a diverse range of applications that can be deployed on-premise or accessed through hosting, encompassing features such as Document Control, Audits, Corrective Actions, Calibration, Training, Material Nonconformance, PPAP, Project Management, Risk Management, and the HQMS Supplier Portal. The platform boasts a strong technical foundation, with capabilities for configuration, personalization, and customization, along with flexible security options, compatibility with any HTML5 browser, and support for Single Sign-On, enhancing user accessibility. Additionally, it seamlessly integrates with ERP systems and other applications, making it versatile for various operational needs. The reach of HQMS extends across multiple sectors, including manufacturing industries such as Aerospace and Defense, Automotive, Consumer Products, Medical Devices, Food, and Energy, as well as healthcare, retail, non-profit organizations, and government entities. With a strong emphasis on security, the applications ensure that critical functions like Document Control, Audits, and Training are managed effectively, while also allowing for personalization and integration with existing systems. This comprehensive approach not only streamlines processes but also enhances overall organizational efficiency and compliance.

IMSXpress ISO 9001 is an all-encompassing software solution tailored for managing document control and quality systems effectively. The IMSXpress client can be installed on personal computers or a Windows server, which enables remote desktop services for user distribution as a remote application. It utilizes an MS SQL database that can be configured on any version starting from MS SQL Server 2014, allowing access to the IMSXpress application through various types of networks. For remote connectivity, users can establish their own network, opt for a cloud hosting service, or select an online subscription plan. The software also boasts an automated training module, which comprises self-training options, integrated document training, and comprehensive job descriptions, among other educational materials. Designed to accommodate modifications in documents, engineering, and processes, it allows users to create and fill PDF templates with ease, generating necessary records effortlessly. Furthermore, IMSXpress is instrumental in scheduling maintenance, managing spare parts inventory, and addressing complaints, non-conformities, risk assessments, and audit findings. This multifaceted nature of IMSXpress ensures that organizations not only uphold high quality management standards but also enhance their operational efficiency seamlessly. By integrating such a robust system, companies can foster continuous improvement and adapt to evolving industry demands with greater agility.

uniPoint provides a versatile modular quality management software that functions on-site. This solution integrates effortlessly with multiple ERP systems, enhancing its adaptability. It serves manufacturers from various sectors and production techniques. Users can effectively manage processes such as document control, equipment management, non-conformance tracking, and the administration of corrective and preventive actions, ensuring thorough quality oversight. Moreover, the software's flexibility significantly boosts operational efficiency and ensures compliance across a wide range of manufacturing settings. Its robust features empower businesses to maintain high standards while adapting to ever-changing industry demands.

Ennov Doc is a component of Ennov's ECM platform tailored for regulated industries, particularly within the Life Sciences Sector. This solution has earned recognition from Gartner as a significant player in the Life Sciences field, highlighted in their Hype Cycle for Life Sciences Reports as a Regulated SaaS EDMS, in addition to its mentions for eTMF and QMS, making it suitable for both large and smaller organizations. It integrates various functionalities within a single interface, including Document Management (EDMS), Business Process Management (BPMS), Dossier Management, Report Management, and ensures Traceability and Security compliant with 21 CFR part 11. The platform features a user-friendly, entirely web-based interface that facilitates straightforward deployments and fosters high levels of user adoption. Furthermore, a standout characteristic of the document management system is its "metadata-oriented" approach, allowing for customizable navigation and search capabilities that rely on metadata instead of traditional folder structures. As a result, users can efficiently locate documents based on their content rather than their physical location, enhancing productivity and streamlining workflows. This focus on intuitive design and flexible document retrieval further cements Ennov Doc as an essential tool for organizations in the regulated industries.

Maintaining consistent product quality and effective quality management systems presents considerable obstacles in today's pharmaceutical manufacturing environment. Sectors subject to rigorous regulations, such as Pharmaceuticals, Biotechnology, and Life Sciences, are required to follow Good Manufacturing Practices (GMP) to meet legal requirements. However, simply meeting GMP standards is not sufficient; organizations must also demonstrate compliance through proper documentation. Utilizing paper-based forms, disconnected systems, or manual processes to manage, track, and document quality-related issues and their resolutions does not provide adequate solutions for creating cohesive and integrated quality management systems that meet industry expectations. As a result, it becomes imperative for organizations to adopt more sophisticated and automated solutions to bolster their quality assurance initiatives and facilitate smoother compliance processes, ultimately leading to improved operational efficiency and product safety.

Quality Collaboration By Design (QCBD) provides a robust quality management software solution specifically designed for the manufacturing industry. This affordable application is compatible with Windows and effectively simplifies the tasks associated with achieving and maintaining compliance with multiple quality management standards, such as ISO 13485, ISO 9001, TS 16949, AS9100, and SQF 2000 / ISO 22000. Created by CAMA Software, QCBD includes an extensive array of modules that support functions such as training management, supplier oversight, tracking process deviations, document control, and equipment management, among others. Its intuitive user interface not only boosts operational efficiency but also allows businesses to swiftly adjust to changing quality standards. Furthermore, QCBD empowers organizations to foster a culture of continuous improvement, ensuring they remain competitive in an ever-evolving marketplace.

ARMATURE Fabric™ offers a comprehensive platform for overseeing every facet of your accreditation, certification, credentialing, audit quality, and compliance processes. By utilizing our software, you can enhance your efficiency, save valuable time, and provide improved service to your stakeholders. No matter if you are responsible for institutional, programmatic, or specialized accreditation initiatives, certifying individuals, products, or organizations, conducting audits or assessments, or addressing non-conformances, ARMATURE Fabric streamlines these operations, benefiting both you and your stakeholders in the process. Our secure, cloud-based software enables diverse data collection methods, including online applications, audits, assessments, and self-evaluations. Furthermore, it allows you to effectively manage all workflows related to accreditation, certification, audits, and compliance, while also facilitating document and artifact management, issue resolution, report generation, and trend analysis, ultimately empowering your organization to operate at its best. This holistic approach ensures that every aspect of your compliance needs is met with precision and ease.

NWA Quality Analyst®, recognized for its excellence in SPC charting and analysis, stands out as the top choice. It delivers an unparalleled mix of power, user-friendliness, and adaptability compared to other SPC software available. This tool enables users to visually assess process dynamics and gauge the effectiveness of enhancements made to those processes. Furthermore, its intuitive interface makes it accessible for users at all skill levels, ensuring a broad range of professionals can benefit from its capabilities.

QHSE, constructed and managed directly on the Salesforce platform, is recognized as the rapidly expanding Enterprise Quality, Health, and Safety Management System. By integrating EQMS with EHS, Unified QHSE solutions assist businesses of varying sizes in providing safe and sustainable products and services while maintaining high quality standards. These solutions effectively minimize risks and inefficiencies, safeguarding not only the customers and employees but also the integrity of the brand itself. As a result, organizations can operate more seamlessly and confidently in today's competitive market.

SoftExpert EQM is a comprehensive enterprise quality management software (EQMS) that supports organizations in achieving and maintaining ISO 9001 certification by automating and improving quality processes tailored to their specific products, operations, and business methodologies. This flexible and modular platform consolidates all vital quality initiatives, which encompass process mapping and the management of documented information, such as standard operating procedures, work instructions, and records, in addition to handling non-conformance reports, corrective and preventive actions, and quality metrics. Moreover, the software adeptly manages supplier relationships, resolves customer complaints, conducts quality audits, oversees training and competencies, and assesses quality risks and controls, including quality inspections and statistical process control, thus fostering a more agile and robust quality management system. By optimizing these various functions, SoftExpert EQM enables organizations to significantly elevate their overall quality performance and regulatory compliance, ultimately leading to enhanced customer satisfaction and operational efficiency. This powerful tool not only streamlines processes but also provides valuable insights that help drive continuous improvement initiatives within the organization.

The AssurX platform serves as an advanced software solution for enterprise quality management (EQMS) and regulatory compliance, enabling effective communication and coordination of information, documentation, and activities. By utilizing AssurX, regulated organizations can swiftly pinpoint and manage quality concerns and risk factors, thereby preventing issues related to quality or compliance while also enhancing workflow efficiency. The QMS software from AssurX is specifically designed to be customizable, accommodating both stable and evolving business needs. It establishes a digital workflow encompassing tasks, alerts, escalations, and approvals, which can be automated according to specific requirements, accurately reflecting real-world processes. There is no other system that matches its ease of deployment, configuration, and adaptability, making it a standout choice for businesses. In addition, AssurX solutions work together seamlessly to form an interconnected quality management system. These offerings include features such as audit management, corrective actions, training management, complaint management, document management, change control, risk management, and EHS incident management, among others, ensuring comprehensive coverage of quality management needs. Ultimately, the integration of these solutions supports organizations in achieving higher standards of quality and compliance across their operations.

Software designed for regulatory compliance is essential for organizations like Fannie Mae, Wendy's, and Walmart, who rely on a top-tier mobile inspection and audit platform. By utilizing such tools, you can significantly enhance both safety and accuracy within your operations. FORM OpX stands out as the leading field management platform, revolutionizing the way teams interact with Excel, paper, and digital processes. It integrates sophisticated data collection alongside customizable workflows, offering vital operational insights that boost real-time compliance. To promote adherence to regulations, you have the option to implement audits, inspections, or tailored workflows. With digital forms, data can be captured effectively while steering teams toward appropriate actions. Automated alerts can be configured to escalate issues, ensuring timely corrective measures are taken when necessary. Through the creation of personalized workflows, you can streamline processes, enhance compliance, and minimize errors, ultimately saving both time and resources. This approach not only fosters a culture of accountability but also empowers teams to operate with greater efficiency.

To enhance the efficiency of your production floor, integrate manufacturing, MES, and supply chain software into a cohesive system. Discover how DELMIAworks, previously known as IQMS, can enhance transparency across your manufacturing processes and tackle the toughest production challenges. By minimizing downtime, you can boost manufacturing efficiency, product quality, profit margins, and overall operational excellence. Access to real-time data throughout the supply chain significantly enhances decision-making capabilities. A single system can accommodate all ERP, manufacturing, MES, and supply chain needs. Streamlining your operations through automation can drastically reduce both your investment and ongoing maintenance expenses. With our user-friendly solution, you can significantly increase your plant's output while reducing human errors and refining production planning efficiency. To further mitigate unplanned downtime and maximize throughput, it is essential to effectively manage, monitor, and track every facet of the production line. Additionally, OEE graphs and charts receive dynamic updates with real-time performance and quality metrics, ensuring you have the latest insights at your fingertips. By implementing this comprehensive approach, you can transform your manufacturing environment into one that is both agile and resilient.

SpineNEXTGEN is a robust ERP solution specifically designed for pharmaceutical companies, ensuring compliance with GST regulations. It boasts a comprehensive suite of advanced features that facilitate effective management of costs, sales, and purchases, making it the leading ERP software within the pharmaceutical industry. There has been a persistent demand in the market for an ERP system that addresses the distinct challenges faced by the pharmaceutical sector. By implementing SpineNEXTGEN, businesses can fill this gap, providing state-of-the-art ERP solutions that allow for the comprehensive management of all operational aspects from a unified platform. For organizations seeking an outstanding ERP software tailored for both manufacturing and management in the pharmaceutical arena, SpineNEXTGEN is certainly the perfect option! Furthermore, this cutting-edge software not only improves operational efficiency but also equips companies for sustainable expansion in an increasingly competitive marketplace. Its user-friendly interface and customizable features further enhance its appeal to pharmaceutical firms looking to optimize their processes.