Best Medical Quality Management Systems for Windows of 2025

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.

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.

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

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.

It can seem like a never-ending series of tradeoffs to bring breakthrough products to market within highly regulated industries. MasterControl's GxP software simplifies workflows, so you don't have to compromise quality for cost or innovation with regulation. Complete and connected meets flexible and fast. MasterControl Quality Excellence transforms quality data and processes to a competitive edge. Modern software is the first step in modernizing your manufacturing operations. MasterControl Manufacturing Excellence, from work orders to production records (EBR/eDHR), to logbooks and work instructions, is the easiest way to digitalize manufacturing.

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.

Orcanos is an integrated software solution for ALM (Design Control), and quality management (QMS) that allows you to deliver products on time and within budget. Orcanos is a cloud-based solution that supports Requirements Management and Test Management, Document Control, Risk Management and Quality Management. Orcanos features dashboards and real time alerts to help businesses keep track of their ongoing projects and have real-time visibility on their progress.

Paradigm 3 is both a web- and desktop-based platform that helps businesses manage compliance in document control, CAPA compliance, Competency Tracking, Training, and Document Control. The software includes tools such as an event manager to handle customer complaints and incident investigations, as well as tasks sent by e-mail and audit preparations. Paradigm 3 is beneficial to the following industries: Manufacturing, Test Labs, Healthcare, and Service Industries.

HQMS applications, available on-premise or hosted, including Document Control, Audits, Corrective Action, Calibration, Training, Material Nonconformance, PPAP, Project Management, Risk Management and the HQMS Supplier Portal. Robust technical capability, including, configuration, personalization, and customization, with flexible and customizable security options, any HTML5 browser, Single Sign-On, and more. Integration with ERP and other apps. HQMS across several markets, including manufacturing (Aerospace and Defense, Automotive, Consumer Products, Medical Device, Food, Energy, and more), healthcare, retail, non-profits, and government.. Highly secure Document Control, Audits, Corrective Action, Calibration, Training, and the HQMS Supplier Portal with personalization, configuration, customization, and integration.

UniPoint's Quality Management Software can be used on-premise to manage quality. Quality Management Software is easy to integrate with other ERP systems. Quality Management Software can be used by manufacturers of any 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.

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.

Quality Collaboration By Design (QCBD), a fully integrated quality management solution, is designed for manufacturing businesses. This Windows-based, affordable application makes it easier to achieve and maintain compliance with quality management standards like ISO 13485 and ISO 9001. CAMA Software's QCBD module offers a variety of modules for supplier management, training management, process deviations management, document control, equipment and more.

ARMATURE Fabric™, allows you to manage all aspects of your accreditation, certifications, credentialing, audit quality, and compliance activities from one platform. Our software allows you to save time, work more efficiently and securely, and better serve your stakeholders. Whether you manage institutional, programmatic or specialized accreditation programs, certify individuals, products or organizations, conduct audits or assessments, or resolve non-conformances, ARMATURE Fabric can make it simpler and more efficient for both you and your stakeholders. Our cloud-based, secure software allows you to collect data in multiple methods (through online applications and audits, assessments and self-evaluations), manage your accreditation, certification, audit and compliance workflows, capture and manage documents and artifacts and identify and resolve issues; generate reports; and spot trends.

NWA Quality Analyst®, an award-winning SPC charting and analysis solution, is the best. It offers the best combination power, flexibility, ease-of-use, and flexibility of any SPC software. It allows users to visually analyze process behavior and evaluate the impact of process improvements.

Natively built and operated on the Salesforce platform, QHSE is the fastest growing Enterprise Quality, Health and Safety Management System. Unified QHSE solutions combine EQMS with EHS to help customers of all sizes deliver high quality products and services in a safe and sustainable manner. They reduce risk, inefficiencies, and inefficiencies, while protecting their customers, employees, and brand.

SoftExpert EQM (enterprise quality management software) is the most comprehensive. It assists companies in achieving and maintaining ISO 9001 certification by automating highly interactive quality processes that are tailored to their 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 can also manage supplier relations, customer complaints and quality audits, as well as competence and training, quality controls, quality inspection, and statistical process control, increasing QMS flexibility and robustness.

The AssurX platform is a powerful software platform for enterprise quality management (EQMS) and regulatory compliance to reliably communicate and coordinate information, documentation, and activities. AssurX allows regulated businesses to quickly identify and control quality issues and risk exposure to avoid quality or noncompliance problems while improving workflow. AssurX QMS software is uniquely 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. No other system is easier to deploy, configure, and modify. AssurX solutions integrate seamlessly to create a connected quality system. Solutions include audit management, corrective actions, training management, compliant management, document management, change control, risk management, EHS incident management, and more.

Software that helps you comply with regulations. Fannie Mae, Wendy's and Walmart trust the best mobile inspection and audit platform. This will help you improve safety and accuracy. The #1 field management platform for teams, FORM OpX will transform your Excel, paper, and digital processes. FORM OpX combines advanced data gathering and configurable workflows with powerful operational insight to increase compliance in real time. To ensure compliance and team compliance, you can set up audits, inspections, or workflows. Digital forms allow you to capture data and guide teams to the right actions. Set up automated alerts and escalates to prompt corrective action when issues arise. You can save time and money by creating customizable workflows that improve processes, increase compliance, and reduce errors.

In today's pharmaceutical manufacturing environment, it can be difficult to maintain consistent product quality and quality processes. To meet regulatory requirements, industries like the Pharmaceutical, Biotech and Life Sciences must maintain Good Manufacturing Practices (GMP). You must not only meet GMP requirements, but you must also be capable of proving it.

To optimize your shop floor, combine manufacturing, MES and supply chain software. Learn how DELMIAworks, formerly IQMS, can help you improve visibility into every aspect your manufacturing operation and solve the most difficult production problems. Reduce downtime and increase manufacturing efficiency, quality, profit margins, and quality. Real-time data access across the entire supply chain can improve decision making. All ERP, manufacturing, MES and supply chain requirements can be handled by one system. Automating your business can lower your investment and maintenance costs. Our simple-to-use solution will double your plant output, eliminate human error, and improve the efficiency of production planning. To eliminate unplanned downtime, increase throughput and reduce downtime, manage, track and monitor all aspects of the production process. OEE graphs and charts are dynamically updated with performance data and quality data in real time.

SpineNEXTGEN, an ERP solution that is GST compliant for pharma companies, is the only step. SpineNEXTGEN ERP software is the best choice for pharmaceutical companies. It offers a wide range of cutting-edge features including cost, sales and purchase management. For a long time, there has been a shortage of an ERP system that is competitive in the pharmaceutical industry. SpineNEXTGEN offers a solution to this problem, offering the best pharma ERP software for companies that want to manage all aspects their business from one place. SpineNEXTGEN is the best ERP software to manage manufacturing and management in the pharmaceutical industry.