Best Medical Quality Management Systems for On-Premises 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®, a modern product lifecycle management (PLM), system, connects people and processes across functional silos with a digital thread for innovative. You can solve more of the difficult problems required to create high-quality products due to the unmatched breadth of the Teamcenter portfolio. The Teamcenter user interface is simple and intuitive, allowing everyone in the organization to take part in product development. No matter how Teamcenter is deployed - on-premises, cloud, or via TeamcenterX - you will get the same proven solutions that help you innovate faster. Start Teamcenter by gaining control over product data and processes. This includes 3D designs, embedded software, documentation, as well as your bill of material (BOM). Your PLM system will yield greater returns if you leverage your product information across multiple domains and departments.

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

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.

1factory's Manufacturing Quality software is cloud-based and on-premises and was specifically designed for manufacturing companies of any size. 1factory's Manufacturing Quality is a reliable and secure solution that allows for first article inspections and factory monitoring. It also provides quality control plans, in process and final inspections, inspection management, CAPAs and non-conformances. Other key features include the ability to calculate Process Performance (Ppt, Ppk), and Process Capability (Cpt, Cpk), variation/SPC control management, defect risk monitoring, and many 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.

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.

Enterprise Quality Management Software in cloud for life sciences. Technology plays a crucial role in ensuring that QA is aware of any issues as they arise in today's complex operational environment. You can gain insight into your quality management system's performance and the current state in your operation to be more proactive and reduce risk. Montrium's Enterprise Quality Management system (EQMS), was designed to help life science companies tackle the content management challenges they face head-on. Each module of the SharePoint QMS can be used separately or as part of a fully integrated quality management platform. These modules can be used on-premise or in a cloud environment. These modules are ideal for pharmaceutical companies, contract manufacturers, and medical device companies. Built to comply with GMP/GCP requirements.

Loftware Prisym 360 offers innovative content management features that incorporate industry best practices. It is specifically designed to meet the complex regulatory requirements for clinical supplies labeling. Many clinical labeling teams use English MLT/CLT variants for defining the content of booklets and labels for clinical trials. The number of countries in each study increases and each country has specific regulatory content, phrases, and language requirements. Therefore, the manual process of designing booklets and printing them takes longer and is more risky. Prisym 360's CLT/MLT solution prompts users to provide study information. Then, it automatically generates MLT, CLT, and booklet designs based on its knowledge about content and design requirements. This reduces the time it takes to create a clinical label or booklet, reduces errors and ensures compliance with regulatory requirements.

QualityKick provides a QMS solution for the biological sciences. It is divided into different modules, each of which solves a particular part of the quality-management processes: document control and control of training, change control and control of events, CAPA and risk assessment, as well as audits and qualification of suppliers and equipment. It is a web application that can be accessed anywhere and on any mobile device. It works on all devices: computer, tablet, and smartphone. A guided tour is automatically loaded when new users sign in. You can edit documents in MS Word, and then send them to a configurable review process. You can configure different types of events, such as deviations or nonconformities. CAPA plans can be defined, actions recorded, and their effectiveness verified. Solutions for quality management within the pharmaceutical, biotechnology and medicine sectors.

LabWay LIMS allows you to focus on what you do best, and manage your lab. Integrated digital solutions to organize and manage laboratory information. LabWay LIMS is a LIMS and QMS solution that allows for the computation of all laboratory areas. Its main goal is to promote productivity and process quality improvements. LabWay is a highly-competitive LIMS and QMS for different areas of activities. Proactive communication system, control of records for pending activities and process. Quick and easy-to-use integrated document management that provides verification and evaluation of purchases and orders. Management of internal and outside audits to ensure continuous improvement. Team management that is both efficient and fast. We align management strategy with quality. Management of immediate action and effective resource management. Improved service quality and speed in sending results.

AmpleLogic's Quality Management Software is designed to meet the strict requirements of industries that are heavily regulated. The ISO 9001-certified cloud-based Quality Management System is ideal for Lifesciences and other industries such as Food & Beverages, Cosmetics, Medical Devices or Gene Therapy. Businesses are adopting QMS solutions as they recognize the challenges of manual quality checks, which can be laborious and prone to errors. These systems are crucial in improving audit quality by automating processes, managing data efficiently, and integrating APIs.