Best Medical Quality Management Systems in Asia

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.

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.

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

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.

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.

Arena PLM assists high-tech and medical device firms to quickly design, produce, or deliver innovative products. Arena allows everyone involved in new product development (NPD), and new product introductions (NPI), to collaborate more effectively and ensure regulatory compliance for FDA and ISO, ITAR and EAR.

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.

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.

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.

Your customers and shareholders will be delighted by your profitable products. Buyers have changed. Supply chains are in chaos. The definition of a product is being redefined. However, product development technologies have not kept pace. We need a new approach. One that is focused on patient and customer outcomes. This helps product companies make the right decisions. This engages markets with engaging products and experiences. This is called product value management (PVM). Collaboration with all stakeholders, including suppliers and customers, is essential to develop and launch innovative products. Design for product quality and manage part quality. Take action to resolve quality issues. To engage customers with enhanced omnichannel product experiences, leverage a trusted source of product information.

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.

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.

You can now access your personal Quality Management Expert through an online platform designed for your convenience. With ready-to-use templates that can be seamlessly integrated into your organization, you can ensure efficient operations. Our offerings include comprehensive Quality Management Systems and digital solutions tailored for ISO 13485 related to Medical Devices, as well as ISO 9001 for General Quality Management, providing a robust framework for your quality assurance needs. Take advantage of our services to elevate your quality management practices to new heights.

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.

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.

1factory's Manufacturing Quality is a versatile quality control software designed for manufacturing organizations, available both in the cloud and on-premises. This robust, dependable, and secure solution offers a range of functionalities, including first article inspections, factory monitoring, quality control plans, and various types of inspections such as in-process, final, and incoming inspections, along with comprehensive inspection management, corrective actions for non-conformances, and much more. In addition to these features, it allows users to perform metrics calculations for Process Performance (Pp, Ppk) and Process Capability (Cp, Cpk), as well as manage variation and SPC control, monitor defect risks, and various other essential quality management tasks. Its extensive capabilities make it an ideal choice for manufacturing companies looking to enhance their quality assurance processes.

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.

Streamline tedious and repetitive tasks so you can concentrate on delivering products that are both safer and more effective, and do so at a quicker pace. IQVIA’s SmartSolve Postmarket Surveillance offers a comprehensive SaaS solution for postmarket surveillance (PMS), equipping you with best practices for the centralized management of all PMS activities. The Fusion event, tailored for SmartSolve and RIM Smart users, provides extensive education on pertinent quality and regulatory subjects, offering actionable insights and practical tools applicable across any Life Sciences organization. Initially launched as a live conference for SmartSolve users, Fusion has transformed over recent years to encompass both virtual and in-person events for the broader SmartSolve and RIM Smart communities. Enhance your compliance response times, accuracy, predictive planning, and overall efficiency through the IQVIA SmartSolve™ Regulatory Connector. This Connected Intelligence framework represents our forward-thinking, integrated strategy aimed at fostering significant operational efficiencies across the board, ultimately benefiting your organization in numerous ways. Embrace these advancements to ensure your organization remains competitive in a rapidly evolving landscape.