Navigating eQMS in Medtech today with Greenlight Guru

This video provides an in-depth exploration of navigating Electronic Quality Management Systems (eQMS) in the Medtech industry, featuring a detailed demonstration of Greenlight Guru's platform. The session, hosted by Cannon Quality Group, aims to educate Medtech startups and established companies on the advantages and latest features of eQMS, which is increasingly becoming standard technology. The discussion highlights how eQMS can automate processes, improve compliance, reduce costs, increase productivity, enhance traceability, and alleviate documentation burdens, moving away from traditional lengthy and complex QMS implementations.

Wade Schroeder, a Medical Device Quality Consultant from Greenlight Guru, positions their solution as a "Medical Device Success Platform" rather than just an eQMS, emphasizing its industry-specific design. Greenlight Guru is presented as the only eQMS built exclusively for medical devices, offering an out-of-the-box solution that handles validation for every release, thereby reducing a significant burden for users. The platform integrates core QMS functionalities, including document management with 21 CFR Part 11 compliant electronic signatures and robust change control, comprehensive training management with auto-tracked records, and structured quality processes for CAPA, customer feedback, non-conformances, and audits.

A key differentiator highlighted is Greenlight Guru's multi-level design controls and risk management, which are built to align with ISO 13485, FDA 21 CFR Part 820, and ISO 14971. The platform enables users to build a full design control traceability matrix, linking user needs to design inputs, outputs, verifications, and validations directly within the system. This approach eliminates the need for separate requirement specifications and automatically generates the Design History File (DHF). The risk matrix is seamlessly integrated, allowing for a risk-based approach to design by linking design controls to specific harms and assessing initial and residual risk levels. The system also features an "Intelligent Document Management" system with built-in AI and a "Visualize" tool, which provides a dynamic, interconnected view of the entire quality system, helping users understand the impact of changes proactively.

Key Takeaways:

• eQMS as a Medtech Standard: Electronic Quality Management Systems are becoming essential for Medtech startups, offering significant benefits such as automation, improved compliance, cost reduction, increased productivity, enhanced traceability, and reduced documentation burden.
• Industry-Specific Solution: Greenlight Guru is presented as a unique eQMS specifically designed for the medical device industry, ensuring alignment with sector-specific regulations and best practices, unlike generic QMS platforms.
• Pre-Validated and Continuously Updated: The platform is an out-of-the-box solution that Greenlight Guru pre-validates with every release, removing the validation burden from customers and allowing for continuous product improvements without requiring re-validation.
• 21 CFR Part 11 Compliance: The system supports electronic signatures and maintains a detailed audit trail for all actions, ensuring compliance with 21 CFR Part 11 requirements for electronic records.
• Integrated QMS Ecosystem: Greenlight Guru provides a fully integrated QMS where all elements—documents, projects, training, and quality processes (CAPA, complaints, non-conformances, audits)—are interconnected and traceable, serving as a single source of truth.
• Automated Design History File (DHF): The platform automatically compiles the DHF by linking user needs, design inputs, design outputs, verifications, and validations, significantly streamlining the documentation process for regulatory submissions.
• Risk-Based Design Approach: The system integrates risk management aligned with ISO 14971, allowing users to identify hazards, assess initial risk, link design controls as mitigations, and evaluate residual risk, providing a comprehensive risk file.
• Visual Project Management: Design control matrices include visual indicators (e.g., green/pink for pass/fail, checkmarks for approved items) to help teams track progress and status of verifications, validations, and design reviews.
• Component-Based Design Controls: Complex projects can be broken down into manageable subsections (e.g., software, electrical, mechanical components), allowing for focused reviews and easier navigation while maintaining overall traceability.
• Proactive Change Management with AI: The "Visualize" tool leverages AI and natural language processing to show the interconnectedness of all QMS elements, enabling users to proactively assess the impact of changes across documents, projects, and quality processes.
• Automated Recommendations for Change Orders: When initiating a change order, the system uses its AI capabilities to suggest other documents or items that might be impacted by the change, ensuring comprehensive consideration and reducing oversight.
• Comprehensive Quality Analytics: Dashboards and analytics provide high-level reporting on change orders, CAPAs, audits, and customer feedback, offering insights into organizational quality health and supporting management reviews.
• Scalable Solution: The platform offers different pricing and packaging tiers, allowing companies to start with essential functionalities (documents, change, projects) and add more advanced features as they grow and their needs evolve.
• Context-Aware Communication: The system includes a comment feature that is context-aware, allowing users to add notes specific to a document or quality process and @mention colleagues for direct notifications and collaboration.

Tools/Resources Mentioned:

• Greenlight Guru: The eQMS and "Medical Device Success Platform" demonstrated.
• G2 Crowd: A third-party review site mentioned for checking recommendations for Greenlight Guru.
• Greenlight Guru Academy: An educational platform offering certifications and learning resources for the medical device industry.
• Greenlight Guru Blog/Podcast: Content resources provided by Greenlight Guru for industry insights.

Key Concepts:

• eQMS (Electronic Quality Management System): A software system designed to manage and automate quality processes and documentation in a regulated industry.
• DHF (Design History File): A compilation of records that describes the design history of a finished medical device.
• Design Controls: A set of interrelated practices and procedures that are incorporated into the design and development process of a medical device.
• Risk Management (ISO 14971): A systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk.
• CAPA (Corrective and Preventive Action): A system for identifying and addressing existing nonconformities (corrective action) and preventing potential nonconformities (preventive action).
• 21 CFR Part 11: Regulations issued by the FDA that set forth requirements for electronic records and electronic signatures.
• ISO 13485: An international standard for quality management systems specific to the medical device industry.
• FDA 21 CFR Part 820: The Quality System Regulation (QSR) for medical devices in the United States.
• Visualize: Greenlight Guru's AI-powered tool that graphically displays the interconnectedness of all QMS elements within the system.
• Natural Language Processing (NLP): A form of AI that enables computers to understand, interpret, and manipulate human language, used in Greenlight Guru to auto-link documents based on content.

Examples/Case Studies: The video uses a hypothetical "circuit board" as a central example to demonstrate various functionalities, including:

• Linking the circuit board document to design outputs like an LCD screen or mechanical enclosure.
• Showing how a complaint about the circuit board would be linked in the customer feedback and CAPA modules.
• Illustrating how changes to the circuit board would trigger a change order and how the "Visualize" tool would show all impacted documents and design controls.
• Discussing how different components (electrical, mechanical, software) can be managed within a single project's design control matrix.