Best Medical Quality Management Systems with a Free Trial of 2026

Propel offers a comprehensive Medical Quality Management System tailored specifically for the highly regulated medical device sector. This system ensures that quality management processes—such as handling nonconformances, implementing CAPAs, managing complaints, conducting audits, and overseeing change control—are entirely traceable and linked with product data. By employing a closed-loop methodology, Propel facilitates adherence to FDA and ISO standards while enhancing operational effectiveness. The platform empowers manufacturers in the medical device field to mitigate risks, enhance preparedness for audits, and preserve an organized, governed history of all quality-related decisions. With nearly 50% of its clientele in the medical device industry, Propel has demonstrated its effectiveness in environments subject to stringent regulations. The Propel One for Quality suite introduces AI-driven features that provide automated insights and generate training quizzes, aiding teams in reinforcing compliance, closing knowledge gaps, and fostering ongoing improvement. Designed for scalability and adaptability, the platform accommodates changing regulations without hindering innovation, all while ensuring enterprise-level security suitable for regulated sectors.

A cloud LIMS that tracks samples, tests results, and manages inventory for life science research, industrial QC labs, and biotech/NGS. Includes regulatory support for CLIA and HIPAA, Part 11 and ISO 17025. The quality, security, traceability, and traceability for samples is crucial to a lab's success. Laboratory professionals can use the Lockbox LIMS system to manage their samples. They have full visibility of every step of the sample's journey from accession to long-term storage. LIMS analysis is more than just tracking results. Lockbox's multilayered sample storage and location management functionality lets you define your lab's storage structure using a variety location options: rooms and storage units, shelves and racks, boxes and boxes.

TLM QMS Software is a powerful and robust quality, risk and material management software (QMS) which is validated and 21 CFR Part 11 compliant. TLM is a cutting-edge, all-in-one quality management system that can be customized to integrate with online CRM software, QuickBooks or ERP databases. Total Lean Management (TLM) QMS Software is specifically intended to be a low cost, highly integrated, flexible and continuously improving landscape to which specialty systems can be added where needed to create the digital business landscape that enables work flows the way your company needs them to work.

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. Best For 1. For companies who need guidance to implement and adopt validated QMS. 2. For companies who want to automate their quality management and go beyond a paper-based system.

Intellect's QMS software has been proven to improve quality operations and reduce overall quality cost by up to 40%. Our apps were designed by certified quality professionals and can be easily customized with our no-code platform or drag-and-drop technology. Remote access for your team, mobile apps, dynamic workflows, analytics, reporting, and remote access are all possible with this modern and simple solution. Apps include Document Control and Employee Training, Audit Management CAPA, Nonconformance, as well as other useful features.

Qualityze EQMS Suite is a next-generation Enterprise Quality Management Software. It is specifically designed for businesses to efficiently manage their quality processes, customer expectations and compliance requirements. It helps them address operational challenges so they can achieve excellence in terms of quality, safety and reliability. It comes with pre-defined templates for controlled documents, audit checklists, regulatory forms, material compliance reports and many more. Qualityze EQMS Suite is a set of 14 integrated modules that help create a closed-loop system to manage end-to-end quality from anywhere. Our range of smarter quality solutions is built on the Salesforce.com technology platform. These modules are 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, and Maintenance Management, Forms Management and Field Safety Management. Our Quality Management solutions help create a culture of quality and continuous improvements by proactively mitigating quality issues.

ACE Essentials is the pre-validated Electronic Quality Management System Software (EQMS) designed for highly regulated industries. ACE Essentials includes 10 workflows, as well as all the required Standard Operating Procedures (SOPs) and Policies. This ensures that your quality management system is fully compliant from the start. ACE Essentials features include a complete audit trail that tracks every action within the system. This allows you to understand the risks associated assets. Features of ACE Essentials Pre-Configured Workflows Pre-Configured Event Management (Due dates, Scheduling, Reminders) - Pre-Configured Permission Based Security - Pre-Configured Full Documentation - 50+ documents - Multiple Site Capability - No Charge Upgrades for the Product's Life Pre-Configured Tasks Liste - No Validation Period Pre-Configured In System Notifications Pre-Configured Email Notifications

Arena PLM helps high-tech, medical device, life science, and aerospace and defense companies design, produce, and deliver innovative products quickly. Arena enables every participant throughout new product development (NPD) and new product introduction (NPI) to collaborate more effectively while ensuring regulatory compliance with FDA, ISO, ITAR, EAR, and environmental requirements.

Unify quality processes with QT9's all-in-one cloud-based QMS Software Suite. QT9 QMS is a user-friendly quality management software that includes 25+ modules with unlimited scalability. Automate ISO & FDA Compliance with email alerts, To Do lists and FDA 21 CFR Part 11 Compliant Electronic Approvals. QT9 QMS enables Life Sciences, Biotechnology Companies, Medical Device Manufacturers and Pharmaceutical Companies to digitally transform operations. Get real-time status updates and visualize quality metrics up-to-the-minute. QT9 QMS comes with built-in document control, revision-level controls, corrective actions (CAPAs), Nonconforming products and more. Advance product releases with Deviation Management, Engineering Change Orders, FMEA, Inspection Management Modules Included. Go paperless & put time-consuming tasks on autopilot. QT9 QMS comes ready-to-use. Get a free product tour! Start a Free Trial. Visit QT9qms.com

Dot Compliance offers the industry's first ready to use Quality Management Solution powered by the Salesforce.com platform. The Dot Compliance solution includes an extensive set of off-the-shelf ready eQMS and compliance pre-configured processes, enabling customers to deploy quickly and cost effectively. Dot Compliance ready to use solutions include full project validation services and product validation packages. Dot Compliance offers the industry’s most cost-effective quality and compliance management solution available, allowing users to quickly deploy flexible and scalable solutions. Automate core quality processes such as Document Management, Training Management, CAPA, Audits, Customer Complaints, Change Management, Supplier Quality, and more. Our solution is fully configurable and offers seamless integration abilities, with easy adaptation and implementation of customer’s specific requirements.

SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry. SimplerQMS 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, and ICH Q10, among others. The system is fully validated according to GAMP5. The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more. SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel. Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.

Ensure timely and budget-friendly delivery of products with Orcanos, a comprehensive software solution for Application Lifecycle Management (ALM) and Quality Management Systems (QMS). This cost-effective cloud-based platform encompasses various functionalities, including Requirements Management, Test Management, Document Control, Risk Management, and Quality Management, all centralized in one repository. Moreover, Orcanos offers intuitive dashboards and real-time alerts, enabling organizations to monitor their projects effectively and maintain visibility on progress as it occurs. The Orcanos e-DMS functions as a complete document management system tailored for users to create, track, search, archive, and approve all documentation pertinent to each phase of launching a medical device. By facilitating quick access to documents related to planning, design, development, manufacturing, and servicing, the e-DMS enhances the efficiency of quality processes while significantly shortening the time to market. Additionally, this streamlined approach allows businesses to focus on innovation and meeting regulatory requirements without sacrificing productivity.

Paradigm 3 is a comprehensive platform available for both web and desktop use, tailored to assist businesses with compliance management focusing on Document Control, CAPA Compliance, and Competency Tracking and Training. This software provides a variety of features, including an event manager for handling incident investigations and customer complaints, email-delivered task notifications, and tools for preparing audits, among others. Industries such as Healthcare, Manufacturing, Test Labs, and Service Industries greatly benefit from the functionalities of Paradigm 3. With this innovative solution, organizations can eliminate the need for multiple additional modules to fulfill their compliance requirements. The system consists of four primary modules equipped with over 50 standard forms designed to address all aspects of Quality, Safety, and Environmental management. Furthermore, our form designer empowers users to create customized forms or modify existing ones, ensuring that every specific need is met seamlessly. This flexibility in form design enhances the platform's utility, making it an indispensable tool for businesses striving for compliance excellence.

1factory's Manufacturing Quality is a versatile quality control software designed for manufacturing businesses of various scales, available in both cloud-based and on-premises formats. This robust and dependable solution offers a comprehensive suite of features, including first article inspections, factory monitoring, quality control plans, as well as in-process and final inspections. Furthermore, it also covers incoming inspections, inspection management, corrective and preventive actions (CAPAs), and non-conformance tracking, among others. Additional noteworthy functionalities comprise the ability to perform metrics calculations for Process Performance (Pp, Ppk) and Process Capability (Cp, Cpk), along with managing variation and SPC control, as well as monitoring defect risks effectively. By integrating these capabilities, 1factory’s Manufacturing Quality ensures that manufacturers maintain high standards of quality throughout their operations.

The EzyPro Adaptive Management system (QHSE) serves as a robust platform for merging compliance, performance, and ongoing enhancement efforts. It functions as a comprehensive solution for compliance, maintenance, and operational oversight, allowing for improved efficiency, information sharing, and collaboration among users. Featuring a modular design, it provides adaptable subscription options tailored to specific requirements. EzyPro Healthcare stands out as a Hospital Quality Management system that incorporates action tracking and dashboards to fulfill standards set by NABH and JCI, acting as a central hub for continuous improvement within healthcare facilities. Additionally, there is an option for remote consultancy services to assist with the implementation process. For the first time, a thorough maintenance management solution is paired with the QHSE Management system, aimed at prolonging the lifespan of equipment while enhancing time efficiency and equipment availability, ultimately leading to reduced expenses and increased profitability. Furthermore, the system includes QR code-assisted asset retrieval, which simplifies the management of work orders related to repairs, maintenance, or asset transfers, making it an invaluable tool for organizations. This innovative approach not only streamlines operations but also fosters a culture of accountability and excellence within the organization.

Streamline every stage of the development lifecycle with a flexible solution built for SxMD. Efficiently manage design controls from requirements to compliance with end-to-end traceability to mitigate risk. Innovate faster with a flexible item-based approach to documentation designed to meet even the most complex SxMD product needs. Enhance quality management with full traceability from design input to output with a purpose-built software platform that enables a collaborative quality culture across all teams. Take charge of evolving design, quality, and regulatory requirements while empowering team autonomy and get your product on the front line faster. Ensure frictionless alignment between platforms with native integrations for Jira, GitLab, GitHub, Azure DevOps and more. Leverage our REST API to connect with all your tools.

Integrating your Quality, Health, Safety, and Environmental Management systems into a Cloud-based platform and a Mobile App can greatly enhance organizational efficiency. Clients utilizing Mango for their QHSE compliance come from a diverse range of industries and are situated in various regions, including the United Kingdom, Australia, New Zealand, and South Africa. The assurance of our ISO 9001 and ISO 27001 certifications underscores our commitment to quality management and the protection of your information. By leveraging Mango, your consulting firm can unlock new recurring revenue streams while providing substantial value to your clients, setting you apart from the competition. The Cloud-based nature of Mango indicates that it represents the future of compliance management in the industry. With Mango in your arsenal, you can offer your clients a more streamlined and cost-effective approach to fulfilling their compliance requirements, all while simplifying their processes. As a widely recognized Compliance Management solution created by Mango Limited, it continues to evolve to meet the needs of various organizations.

Honeywell's TrackWise Digital® serves as an innovative cloud-based Quality Management System (QMS) aimed at enhancing the efficiency of quality and compliance processes within organizations. Drawing on nearly thirty years of expertise in the field, it features integrated modules that cater to various elements of quality management, such as document control, training oversight, and corrective and preventive actions (CAPA). The platform utilizes cutting-edge digital technologies, including artificial intelligence and machine learning, to deliver actionable insights in real-time, which fosters a proactive approach to quality management. Its adaptable, modular framework ensures smooth integration with current enterprise systems, allowing for quick deployment and growth. By optimizing quality processes and maintaining adherence to industry regulations, TrackWise Digital® enables organizations to accelerate product launches while effectively reducing risks. This comprehensive system not only enhances operational efficiency but also supports continuous improvement initiatives across the quality management spectrum.

IMSXpress ISO 9001 serves as comprehensive software for document control and quality system management. Users can install the IMSXpress client on individual PCs or on a Windows server, which allows for distribution to users through remote desktop services as a remote application. The underlying database operates on MS SQL and can be set up on any version from MS SQL Server 2014 onward, with access to the IMSXpress application available across various network types. Options for remote access include setting up your own network, utilizing the cloud-based hosting service, or opting for an online subscription package. The system features a fully automated training module that includes self-training, integrated document training, and job descriptions, among other resources. It is designed to facilitate changes in documents, engineering, and processes, enabling users to create fillable PDF templates, populate them with data, and generate records effortlessly. Additionally, IMSXpress is useful for scheduling maintenance tasks, managing spare parts inventory, and overseeing complaints, non-conformities, risk management, and audit findings. This versatility ensures that organizations can maintain high standards in quality management while streamlining their operational processes.

QAPI360 is a comprehensive, cloud-based software solution designed for Quality Assurance Performance Improvement (QAPI) that complies with HIPAA regulations, enabling healthcare providers to centralize, organize, and monitor all aspects of their quality programs. By moving away from outdated spreadsheets and disjointed methods, agencies can adopt a systematic, data-driven framework that includes well-structured QAPI plans, quality metrics, and tracking for incidents involving patients and staff. The software also features infection control monitoring, logs for medication errors and adverse drug reactions, hand hygiene initiatives, templates for performance improvement projects, patient satisfaction assessments, and tracking of contracted provider performance, all displayed through interactive dashboards that allow users to identify trends, implement corrective measures, and evaluate results effectively. Additionally, QAPI360 simplifies data entry, supports EMR integration or automated data imports, and provides built-in reporting tools, which facilitate compliance documentation and audits while enhancing the efficiency of data collection, charting, and root-cause analysis processes. Ultimately, this software serves as a vital resource for healthcare agencies striving to enhance their quality assurance initiatives and ensure optimal patient care.

ZenQMS improves the quality compliance profiles life sciences companies through a cloud-based platform. It is purpose-built to facilitate document collaboration, control, training, issues management, audits, and change management. ZenQMS is a team of technology and quality leaders who share the common goal of making quality management a business imperative.

uniPoint offers a flexible modular quality management software that operates on-premise. This software seamlessly integrates with various ERP systems, making it highly adaptable. It caters to manufacturers across different product lines and production methods. Users can efficiently oversee processes including document control, equipment oversight, non-conformance tracking, and corrective and preventive action management, among others, ensuring comprehensive quality management. Additionally, the software's versatility enhances operational efficiency and compliance across diverse manufacturing environments.

Ennov Doc is part of Ennov's ECM platform for regulated industries, especially the Life Sciences Sector. Our solution is recognized by Gartner as a relevant actor in the Life Sciences sector (mentioned in Gartner's Hype Cycle for Life Sciences Reports as a Regulated SaaS EDMS, as well as for eTMF and QMS) , and suitable for large as well as small organizations. It comprises in the same interface and completely integrated : Document management (EDMS), Business process management (BPMS), Dossier management (composite documents management), Report management, Traceability and security (21 CFR part 11 compliance). With a very intuitive 100% web interface, deployments are easy and user adoption extremely high. Another key point is that document management is "metadata oriented", meaning that documents navigation and search is completely configurable using metadata rather than folder structures. Users can very quickly find documents based on what they are rather than where they are.

Ensuring uniform product quality and robust quality management procedures poses significant challenges in the current landscape of pharmaceutical manufacturing. Industries governed by strict regulations, including Pharmaceuticals, Biotechnology, and Life Sciences, must adhere to Good Manufacturing Practices (GMP) to comply with legal standards. Beyond merely fulfilling GMP obligations, it is essential to provide evidence of compliance. Relying on paper forms, isolated systems, or manual procedures to oversee, monitor, and document quality issues and responses fails to offer effective solutions for establishing cohesive and integrated quality management practices that align with industry standards. Consequently, organizations must seek more advanced and automated systems to enhance their quality assurance efforts and streamline compliance.

EQUMAS tailors digital solutions to meet the specific operational requirements of its clients. Our innovative, modular, and multimodal technology enables manufacturing firms to oversee their Quality Management System (QMS) alongside all other operational components seamlessly. While you could opt for different systems to handle quality control, inventory management, equipment oversight, and report generation separately, choosing EQUMAS streamlines your entire workflow through a robust, integrated software solution. This platform incorporates cutting-edge AI technology that facilitates data-driven decision-making, identifying manufacturing irregularities even before human intervention is possible. Every facet of our system is interconnected, promoting real-time communication across the platform. This remarkable capability significantly reduces the time and effort needed to synchronize various software applications to manage all your data collectively. Furthermore, you can effectively oversee each employee by assigning specific roles and responsibilities, as EQUMAS meticulously tracks and retains individual information throughout the system, enhancing overall operational efficiency. In doing so, we empower organizations to optimize performance while ensuring compliance and accountability across all levels.