Greenlight Guru's eQMS is specifically engineered to address the complexities inherent in the MedTech industry, providing a centralized system for medical device companies to develop and manage devices throughout their entire product lifecycle. It aims to eliminate common issues such as critical process gaps often uncovered during audits, which can lead to significant costs and commercialization delays. The software enables organizations to scale operations without roadblocks by centralizing quality processes, product development, training, and supplier management. It ensures robust compliance with critical standards like FDA, EU MDR, and ISO, offering workflows designed to keep companies organized and audit-ready. The platform facilitates rapid onboarding with audit-tested templates and expert guidance, helping teams prove value quickly and launch products with confidence by linking design controls, risk, and quality to prevent delays and disconnected documentation. Greenlight Guru empowers both quality teams with complete control over quality events, training, and document workflows, and product development teams with traceable design controls connected to risk management, allowing them to focus on innovation rather than paperwork. It provides a smarter, single system solution for managing the entire device lifecycle, from initial market entry to portfolio management, ensuring continuous organization and compliance.

Features & Benefits

• Design Controls
  • Manages design and development in a connected system, automatically linking user needs, inputs, outputs, verifications, and validations to build an inspection-ready Design History File (DHF).
• Document Management
  • Centralizes storage, organization, and management of all documents in a validated system, featuring version history, audit trails, and real-time visibility into approvals to prevent commercialization delays.
• Change Management
  • Streamlines tracking of every change with assigned reviewers, Part 11-compliant e-signatures for approvals, and automated generation of critical change documentation for audit readiness.
• Risk Management
  • Integrates risk throughout the product lifecycle, allowing users to build risk matrices, link design controls and documents as risk control measures, and maintain a dynamic, audit-ready Risk Management File.
• CAPA & Nonconformance
  • Facilitates quick resolution of issues with full traceability by capturing and managing Corrective and Preventive Actions (CAPAs) and nonconformances in one place, complete with linked documentation, assigned tasks, and real-time tracking.
• Audit Management
  • Simplifies internal and supplier audits by allowing direct execution from the QMS, tracking findings, assigning actions, and centralizing evidence for a clear, continuous record of compliance.
• Supplier Management
  • Provides a centralized workspace to track supplier qualifications, store documentation, and link supplier performance to quality events, ensuring compliance and collaboration.
• Training Management
  • Automates training assignments when documents change, tracks completion in real-time, and maintains full traceability of training records to keep teams compliant.
• Always Audit-Ready
  • Ensures continuous readiness for inspections by maintaining complete traceability and version control within a single system.
• Efficient Compliance
  • Automates routine quality tasks such as training, changes, and CAPAs, reducing manual effort required for compliance.
• Accelerated Development
  • Speeds up product development cycles through integrated design controls and risk management, fostering improved team collaboration.
• Scalable Growth
  • Supports the expansion into new teams, products, and markets with a QMS that adapts and grows with the business.