A Comprehensive Solution for Audit Preparedness
Greenlight Guru offers a revolutionary connected quality ecosystem that ensures every aspect of your Quality Management System (QMS) is meticulously organized, centralized, and easily traceable. This comprehensive system empowers your organization to be audit-ready at a moment's notice, providing you with the confidence and peace of mind needed to face any type of audit with ease. By leveraging Greenlight Guru, you gain a valuable extension to your team, enabling you to navigate the auditing process efficiently and effectively.
Testimonials Highlighting Success
Customers like Ryan Nolan, Co-Founder and VP of Clinical Operations at Photonicare, have affirmed the crucial role that Greenlight Guru plays in efficiently guiding them through the Quality Management System process and assisting in the development of FDA submissions. Such testimonials underscore the real-world impact and tangible benefits that organizations experience when utilizing Greenlight Guru's solutions.
Comprehensive Product Features for Audit Management
Greenlight Guru's platform offers a wide array of features specifically designed to streamline and optimize the audit management process. From document management and design control to risk management, change management, training management, CAPA (Corrective and Preventive Actions) management, complaint management, nonconformance handling, project management, and supplier management, Greenlight Guru's comprehensive suite of tools covers every aspect of audit readiness. Additionally, the platform facilitates efficient product management, product change management, and integrates features like Electronic Case Report Forms (eCRFs) and Electronic Patient Reported Outcomes (ePROs) for enhanced clinical data collection.
Access to Resources and Support
In addition to its advanced platform, Greenlight Guru provides a wealth of resources to support its users in achieving audit readiness. These resources include an ROI calculator, insightful blog posts, a medical device glossary, podcasts, webinars, events, customer stories, checklists and templates, eBooks and guides, and a repository of thought leadership articles. The company also offers comparison reports with other industry solutions, highlighting the advantages of choosing Greenlight Guru for audit management.
Guidance for Regulatory Compliance and Best Practices
Greenlight Guru goes beyond offering a technology platform by providing guidance on regulatory compliance and industry best practices. The company shares valuable resources on key standards such as ISO 13485, ISO 14971, ISO 14155:2020, 21 CFR Part 820, 21 CFR Part 11, 510(k) submissions, design controls, design verification, CAPA methodologies, IQ/OQ/PQ protocols, Electronic Data Capture (EDC) systems, electronic Case Report Forms (eCRFs), and much more. By equipping users with this knowledge, Greenlight Guru ensures that organizations are well-prepared to meet regulatory requirements and excel in audit management.