Greenlight Guru

Greenlight Guru: Quality Management Software (QMS) for Medical Device Companies

Greenlight Guru is a cloud-based Quality Management Software (QMS) specifically designed for medical device companies to ensure compliance with FDA, ISO, and other regulatory standards. Greenlight Guru simplifies the design, development, manufacturing, and post-market management of medical devices by integrating quality management with product lifecycle management (PLM). The platform helps medical device manufacturers bring safe, high-quality products to market faster while maintaining compliance and reducing risk.

Greenlight Guru’s QMS is tailored to meet the unique needs of the medical device industry, offering a wide range of tools that cover design controls, risk management, CAPA (Corrective and Preventive Actions), supplier management, and document control. It also enables companies to efficiently manage audits and prepare for regulatory inspections.

Key features of Greenlight Guru include:

• Design Controls: Greenlight Guru’s Design Control module helps medical device companies track and manage the entire design and development process in compliance with FDA 21 CFR Part 820 and ISO 13485. The system ensures that all design inputs, outputs, and verifications are documented and easily traceable, reducing the risk of non-compliance.

• Risk Management: Greenlight Guru integrates Risk Management throughout the product lifecycle, helping companies identify, assess, and mitigate risks associated with their medical devices. The platform ensures that risk management activities align with ISO 14971 standards and allows companies to document risk assessments, hazard analyses, and risk mitigations effectively.

• Document Control: The Document Control module allows medical device companies to manage their documents in a secure, centralized environment. This includes version control, approval workflows, and audit trails to ensure that all documents are up-to-date and accessible to the right team members, in compliance with regulatory requirements.

• CAPA Management: Greenlight Guru helps companies manage Corrective and Preventive Actions (CAPA) to address non-conformities, product defects, and other quality issues. The CAPA module enables teams to track incidents, investigate root causes, and implement corrective actions to prevent recurrence.

• Audit and Inspection Management: Greenlight Guru simplifies audit preparation by centralizing all quality and regulatory documentation, making it easy to demonstrate compliance during FDA inspections and ISO audits. The platform provides real-time visibility into the status of audits, quality issues, and CAPA investigations.

• Supplier Management: Greenlight Guru includes a Supplier Management module that helps companies monitor and manage their supplier performance and compliance. The platform allows teams to document supplier qualifications, track supplier audits, and assess the quality of supplier-provided materials or services.

• Electronic Signatures and Compliance: The platform supports electronic signatures in accordance with FDA 21 CFR Part 11 and EU Annex 11 regulations. This feature ensures that all documents, approvals, and quality records are compliant with global regulatory standards, reducing administrative burdens during regulatory submissions.

• Post-Market Surveillance: Greenlight Guru enables medical device companies to track product performance in the market and manage post-market surveillance activities. The platform helps capture customer feedback, track adverse events, and manage product recalls, ensuring continuous product improvement and regulatory compliance.

• Training Management: The platform allows companies to track and document employee training related to quality management, design controls, and regulatory requirements. This ensures that employees are properly trained on compliance issues and that their training records are readily available during audits.

• Traceability and Audit Trails: Greenlight Guru provides full traceability of design controls, risk management, CAPA, and other quality processes, ensuring that every change and decision is documented. Audit trails provide detailed records of document changes, approvals, and quality actions for regulatory audits.

• Key Benefits:

  • Cloud-based QMS tailored for medical device companies, ensuring regulatory compliance.

  • Comprehensive design control, risk management, and document control tools.

  • CAPA management to track and address quality issues and non-conformities.

  • Supplier management tools to monitor and assess supplier quality and compliance.

  • Simplified audit preparation and regulatory inspection management.

  • Post-market surveillance tools for continuous product monitoring and improvement.

  • Support for electronic signatures compliant with FDA 21 CFR Part 11.

  • Training management to ensure employee readiness and compliance.

  • Full traceability and audit trails for design controls, risk, and CAPA processes.

For more information, visit the official product page: Greenlight Guru

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