Best Medical Quality Management Systems in South America

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.

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.

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.

Founded in 1989, InfinityQS is the leading provider of Statistical Process Control (SPC) software and services to manufacturers worldwide. ProFicient on Demand automates data collection and analysis during the manufacturing process so you can make real-time process improvement decisions—and prevent defects before they occur. Developed by industrial statisticians using proven methodologies for quality analysis and control, InfinityQS solutions save leading manufacturers millions of dollars each year.

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.

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.

EzyPro Adaptive Management system QHSE (QHSE) enables you to seamlessly integrate compliance, performance and continuous improvement. EzyPro QHSE is a one-stop solution for compliance, maintenance and operational control. You can increase efficiency, share information, collaborate, and increase productivity. Flexible subscriptions are possible with its modular approach. EzyPro Healthcare – Hospital Quality Management System with integrated action tracking, dashboards and dashboards to meet requirements such as NABH or JCI. As a central hub for continuous improvement across the Healthcare unit, it was designed. Remote consultancy service is available for implementation support. QHSE Management System bundled comprehensive maintenance management solution. Increase equipment lifespan, increase time efficiency, and equipment uptime. This will result in lower costs and higher profits. You can easily manage work orders for repairs or maintenance, as well as transfer of assets, using a QR code assisted asset retrieval.

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.

Integrate your Quality, Health, Safety & Environmental Management Systems in the Cloud or on a Mobile Application. Mango is used by many organizations. Our clients are located in the United Kingdom, Australia and New Zealand, as well as South Africa. You can be confident that we are able to manage your quality and information security with our ISO 9001 and ISO 27001 certifications.

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

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'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.

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.

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.

Your team should keep your device history file (DHF), while it is being created. MatrixALM can help you verify the content and assist you in creating documents for certification. Work instructions and processes should be simple, efficient, and easy-to-use. Not SOPs written by someone else. MatrixQMS can help you create a quality management system that works for and against you. Risk management must be integrated into the design process as well as the quality system. Not in Excel files on some servers. The traceability matrix includes the risks associated with our applications. Not when you think your device is ready for release, but while you plan and document your validation and verification activities. MatrixALM provides the complete traceability matrix, from the requirements to the completed tests.

You can now focus on delivering safer and more effective products faster by eliminating repetitive, manual tasks. SmartSolve Postmarket Suveillance by IQVIA is a SaaS solution for postmarket surveillance. It provides best practices for centrally managing all postmarket surveillance activities. Fusion is a SmartSolve/RIM Smart user event. It provides in-depth education on timely and relevant quality topics and regulatory topics, as well as practical insights and tools that can be used within any Life Sciences organization. Fusion began as a live SmartSolve user event. It has expanded over the years to include both virtual and live events for SmartSolve and RIM Smart users. IQVIA SmartSolve™, Regulatory Connector, simplifies, automates, and integrates your compliance response times. Connected Intelligence, our innovative, interconnected approach to operational efficiency, is what we call Connected Intelligence.

A digital quality ecosystem that delivers proactive quality. TrackWise Digital, a cloud-based, industry-leading quality management system, has integrated modules that support quality, compliance, and more efficient and effective decision-making. Users can use quality data to improve their culture of quality and increase company performance through advanced analytics and reporting across all quality processes. TrackWise Digital's Quality Process Accelerators, (QPAs), are based on Sparta’s 25+ years of expertise. They provide quick value and streamline digital quality. TrackWise Digital's QMS is the first to use AI to enhance quality-related decision-making capabilities. This allows for a shift in quality from reactive to proactive.

You now have the option to be your own Quality Management Expert via an online platform. To facilitate smooth processes, templates can be integrated into your company. We offer complete Quality Management Systems as well as online solutions for ISO 13485 Medical Devices, and ISO 9001 General Quality Management.

Greenlight Guru is the only product development and quality management platform designed specifically for medical device companies. The Medical Device Success Platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance, and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits, document control, training, design control, and more. Device makers across the globe are replacing their outdated paper-based and general-purpose legacy quality systems with Greenlight Guru to push beyond baseline compliance and achieve True Quality.