Best On-Premises Medical Quality Management Systems 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.

Teamcenter® software represents a contemporary and flexible product lifecycle management (PLM) solution that integrates individuals and workflows across various functional areas through a cohesive digital thread that fosters innovation. Its extensive and diverse portfolio empowers organizations to tackle the complex challenges associated with creating highly successful products. With a user-friendly interface that is both simple and intuitive, Teamcenter enables team members from all corners of the organization to engage in the product development journey more seamlessly than ever. Regardless of your deployment preference—whether on-premises, in the cloud, or via the SaaS option Teamcenter X—you will access the same reliable capabilities that are tailored to accelerate your innovation. Begin your journey with Teamcenter by managing product data and processes, encompassing 3D designs, electronics, embedded software, documentation, and your bill of materials (BOM). By utilizing your product information across a wider range of domains and departments, you can achieve significantly improved returns on your PLM investment. Ultimately, Teamcenter not only streamlines operations but also enhances collaboration, making it an essential tool for modern product development.

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

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.

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.

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.

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.

Cloud-based Enterprise Quality Management Software tailored for the life sciences sector is essential in navigating today’s intricate operational landscape. With technology at the forefront, it ensures that quality assurance teams are promptly informed of issues as they arise, fostering a culture of proactive management. By gaining a clear view of the quality management system's performance alongside operational conditions, organizations can significantly reduce risks and avoid expensive delays. Montrium has crafted its Enterprise Quality Management System (EQMS) specifically to help life science companies confront their quality management challenges directly, particularly in content management. Our SharePoint QMS modules are designed for flexibility; they can function independently or as part of a cohesive quality management system. These modules are accessible through our Montrium Connect Platform and can be implemented either on-premise or via cloud solutions, making them ideal for pharmaceutical firms, contract manufacturing organizations, and medical device companies. Each component is meticulously built to ensure compliance with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP), thereby supporting organizations in maintaining the highest quality standards. Ultimately, this comprehensive approach not only enhances efficiency but also strengthens the overall integrity of the quality management process.

Loftware Prisym 360 offers cutting-edge content management capabilities tailored to comply with the intricate regulatory demands vital for clinical supplies labeling. Teams responsible for clinical labeling frequently employ English MLT/CLT variants to articulate the details for clinical trial labels and accompanying booklets. As the number of countries participating in each study grows, each with its own set of regulatory content, phrases, and language stipulations, the traditional method of designing and printing booklets consumes more time and resources, heightening the potential for mistakes. By utilizing Prisym 360’s MLT/CLT solution, users are guided to input study-specific information, which subsequently allows for the automated creation of MLT, CLT, and booklet designs based on established content and design criteria. This streamlines the process of producing clinical labels and booklets, reducing the necessary time from weeks down to mere hours, ensuring compliance with regulatory standards, and significantly mitigating the likelihood of errors. Ultimately, this innovative approach enhances the efficiency of clinical supply operations, providing a robust solution to a complex challenge.

QualityKick is a cloud-based Quality Management System (QMS) tailored for the biological sciences sector, designed to enhance compliance and streamline various quality management processes. It offers a suite of modules, each addressing critical components such as document control, training, change management, incident tracking, CAPA (Corrective and Preventive Actions), risk evaluation, qualification, and supplier and equipment audits. Being a web-based platform, it ensures accessibility from any location and on any mobile device, including computers, smartphones, and tablets. New users benefit from an automated guided tour upon their initial login, facilitating a smoother onboarding experience. The system supports document editing with MS Word and enables a customizable review and approval workflow, enhancing collaboration and efficiency. Various event types, including deviations, nonconformities, and customer complaints, can be configured to suit organizational needs. Additionally, it allows users to establish CAPA plans, document necessary actions, and assess their effectiveness, making it a comprehensive solution for quality management in the pharmaceutical, biotechnology, and medical fields. With its user-friendly interface and robust features, QualityKick is poised to transform how organizations manage quality compliance.

LabWay-LIMS enables you to focus on your expertise while efficiently managing your laboratory operations. It offers comprehensive digital solutions designed to streamline the organization and oversight of laboratory information. The primary goal of LabWay-LIMS is to enhance productivity and improve process quality, adapting to various laboratory environments. This competitive LIMS and QMS solution caters to multiple fields of activity. It features a proactive communication system that monitors pending tasks and processes effectively. Additionally, LabWay-LIMS includes integrated document management that is user-friendly, allowing for easy verification and assessment of orders and purchases. It also supports the management of internal and external audits aimed at fostering continuous improvement. By facilitating effective team management, LabWay-LIMS ensures both profitability and speed in operations. We align our quality initiatives with strategic management practices, enabling immediate action and efficient resource allocation. Moreover, it enhances the speed of result delivery, ultimately leading to improved service quality and client satisfaction. With LabWay-LIMS, laboratories can expect a remarkable transformation in their operational capabilities.

AmpleLogic's eQMS is specifically designed to fulfill the stringent demands of industries that are under strict regulations. This ISO 9001 certified cloud-based Quality Management System is particularly well-suited for sectors such as Lifesciences, Food & Beverages, Cosmetics, Medical Devices, Gene Therapy, and others that face similar regulatory scrutiny. With companies recognizing the difficulties tied to manual quality assessments, which are often labor-intensive and susceptible to mistakes, there is a growing trend toward the adoption of QMS software solutions. These advanced systems significantly improve the quality of audits through the automation of processes, effective management of data, and smooth integration via APIs. As a result, businesses can achieve higher levels of compliance and operational excellence. Such transformations are essential in maintaining high standards in today's competitive market.