Is my organization's data and information safe in the cloud?
Yes - it is! Greenlight Guru's software is hosted on Amazon Web Services, which is the hosting service of choice for many fortune 100 companies that include Bayer, Siemens Healthcare, Under Armor, and even the FDA. Our team would be happy to share a system overview that covers data storage, disaster recovery and security in order to clarify any outstanding questions regarding security when using the cloud.
HOW DOES GREENLIGHT GURU HELP MY COMPANY ACHIEVE REGULATORY COMPLIANCE?
Medical device specific regulatory guidance and controls are baked into Greenlight Guru’s eQMS software. The platform includes Part 11 compliant review and approval workflows, fully integrated ISO 14971 Risk Management standards, and facilitates your team’s ability to easily demonstrate compliance with both 21 CFR Part 820 and ISO 13485:2016.
CAN I USE GREENLIGHT GURU'S QUALITY MANAGEMENT SOFTWARE IF I AM ALREADY WORKING WITH A QA/RA CONSULTANT?
Absolutely! Whether you are already working with a trusted QA/RA consultant or need to identify a consultant through our network of trusted partners, many of our customers continue working with consultants in parallel both during and post deployment of their eQMS.
DATA & PROCESS MIGRATIONS
HOW DO I MIGRATE MY EXISTING QMS CONTROLLED DOCUMENTS AND PROCESSES INTO GREENLIGHT GURU?
Greenlight Guru offers several different means of helping transition your existing QMS documents and data into our platform. During the sales process, we’ll work with you to define a plan for transitioning existing documentation into Greenlight Guru. Your dedicated medical device industry expert will also work with you to define how your existing processes will translate into your new quality system powered by Greenlight Guru.
Deployment & Licensing
HOW IS THE SOFTWARE LICENSED? CAN I INSTALL IT ON MY OWN SERVER?
Similar to many modern Customer Relationship Management (CRM) and Enterprise Resource Planning (ERP) platforms, Greenlight Guru is a cloud-based software offered on an annual subscription basis that can be accessed via standard web browsers.
CAN MY MEDICAL DEVICE COMPANY BENEFIT FROM GREENLIGHT GURU'S SOFTWARE IF WE ARE INTERNATIONALLY BASED OR INTEND TO SELL OUR DEVICES INTO INTERNATIONAL MARKETS?
Absolutely! We work with medical device companies in more than 500 cities, on 5 different continents. Regardless of where your headquarters location is or the end markets you intend to sell your devices into, Greenlight Guru can streamline quality for your team. Our software can be used to navigate regulatory pathways and quality system requirements internationally, which allows your team to focus on scaling without worrying about the quality system being a bottleneck.
HOW LONG DOES ONBOARDING TAKE?
Depending on the primary use case each customer defines as their initial focus area, the time to value can range from two to eightweeks.
DO YOU OFFER ADDITIONAL ONBOARDING SERVICES?
Yes, every customer is paired with a dedicated medical device industry expert to guide you through the onboarding process and get your team up to speed. For customers that need supplemental onboarding or training services that go beyond our standard offering, we can work with your team to define an extended scope of onboarding that guides your team to specific milestones in your quality transformation
Will I have to pay for software upgrades?
Never! Greenlight Guru is cloud-based and built on a modern technology stack that allows us to release enhancements and features specifically built for the needs of medical device companies on a regular basis. In addition to not having to pay for the upgrades, Greenlight Guru removes the burden of system validation for your team by providing 21 CFR Part 11 compliant IQ protocol/checklist and completed OQ and PQ reports at no additional charge.