Unlock efficiency with leading cloud-based QMS software, GreenLight Guru
Upgrade your paper-based or generic QMS so you can track quality events, trace design controls to risk, help ensure compliance and more — all in the cloud. Your QMS software is optimized for the unique challenges and strict requirements of MedTech. Connect your people, processes, and data under one single source of truth.
Purpose-built platform for medical device companies
- Built-in controls that align with 21 CFR Part 820 and ISO 13485:2016.
- Flexible review and approval workflows with Part 11 compliant audit trail and e-Signatures.
- Fully integrated Design Controls and Risk Management aligned to ISO 14971.
- LinkAnything drives full lifecycle traceability.
- Zero-effort system validation.
- Drive collaboration with task management, comments, and notifications.
Bring safer, better medical devices to market faster
- Create and update your traceability matrices in minutes, not hours or days. Then easily export records on demand.
- Generate design history files without searching for the required documentation.
- Save time with Part 11 compliant e-signatures, flexible review and approval workflows, revision control, and more.
- Keep your risk management file up to date and avoid costly rework by mitigating potential risks.
Advance the success of your devices already on market
- Remain compliant and manage risk in the face of ISO and FDA changes.
- Identify CAPAs, discover their root causes, resolve them, and report outcomes.
- Manage feedback and complaints, escalate when appropriate, and update your risk management file.
- Conduct internal audits and always be ready for external audits and inspections.
ComplianceWire® training is a proven solution for medical device manufacturers
ComplianceWire Learning and Qualification Management System, part of ULTRUS™ software from UL Solutions, is an award-winning, industry-leading training learning management system (LMS) for compliance and qualification management created for life sciences organizations. It allows users to automate the creation, delivery, and reporting of role-based training, qualification, and compliance programs. It is renowned as the “gold standard” learning management system (LMS) for the life sciences and has been used by the U.S. FDA since 1999 to train more than 70,000 investigators.
ComplianceWire provides a comprehensive approach to regulatory compliance
Globally recognized LMS
e-learning library
Customize your training
Support, when and where you need it
Stay up to date with the latest U.S. Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) training, HIPAAA training, ISO 14971 training
ComplianceWire delivers powerful learning capabilities developed by life sciences experts for FDA-regulated companies. Meet FDA Requirements for GxP training, 21 CFR Part 11, EU Annex 11 and get even more from your LMS with professional support services.
What did Greenlight Guru users have to say?
"We've been using Greenlight Guru for the better part of 3 years now and it really simplifies quality management. It's very easy to get all of our team on the same page and effortlessly trace various efforts through the system."
Ryan Shelton
CEO, PhotoniCare
"Medical device companies must document Design Controls, yet most struggle with this. Greenlight Guru makes this so much easier for us. Another HUGE headache for companies like ours is document management. And Greenlight Guru helps with this too."
Allan Katz
CEO & President, Long Island Technology Group
"We recently passed our ISO 13485 Stage 2 audit, due in part to the ability to demonstrate a comprehensive matrix of risk and design controls. Demonstrating our QMS using a tool like GG was fundamental in this achievement."
Linda Cox
VP QA/RA, beneSol
"We wanted a QMS solution that was robust enough to grow with us, but simple enough to get us started."
Kevin McLeod
CEO at C2DX, Inc.
Join RAMS and bring your medical devices to market faster
Create your complimentary account and see why RAMS is trusted by medical device companies all over the world.
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