Avoid the rework and excess documentation involved with each new quality event opened, by implementing custom CAPA, Nonconformance, Customer Feedback, or Audit workflows to automate the step-by-step process.
Increase your team’s efficiency when managing post-market quality events with custom-built, automated workflows while still working within the guardrails of Greenlight Guru.
Enable a culture of quality by managing quality events like CAPA, Customer Feedback, and Audits in Workspaces with 21 CFR Part 11 compliant review and approval workflows to collaborate with internal and external stakeholders
See how teams are streamlining quality processes →
Easily incorporate ISO 14971:2019 compliant risk-based controls into your quality and design processes throughout both development and post-market surveillance stages.
Assure traceability throughout the product lifecycle by easily linking post market activities to Design Controls, Risks, and Documents
Speed up reviews and approvals by keeping your documents, records, and procedures organized, up-to-date and always accessible to the right people with robust sharing and role based security.
See Advanced Document Management in action →
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G2 Crowd provides real-time and unbiased user reviews to help you objectively assess what software is best for your business.
With Greenlight Guru, I can follow all the steps of our quality management system and make sure all regulatory requirements are met. The most significant benefit for me is being able to accurately verify that all risks are managed and that all design checks are carried out. The software allows us an extremely rigorous follow-up which is and will be a big help for us.
We are solving document control and design controls with the Greenlight Guru Software. It is easier to release documents and gather signatures for controlled documents. The design controls system has made project management more manageable by having all the documents in one place.
The Greenlight Guru customer success team has helped us navigate the entire process so far, with no ask too large and no question left unanswered. It has by far been one of the best customer service experiences I've had to date.
Having come from one of the largest medical device companies globally to a start-up with no QMS, yet alone, an eQMS, the transition to Greenlight has saved my team countless hours and provided an ability, especially during COVID, to do remote approvals of documents, assign tasks, and give visibility to the appropriate team members of a variety of modules in order to collaborate and move forward with pre- and post-market activities.
#1 - Customer Service! Our Customer Success Manager and Medical Device Guru are both incredibly patient and responsive anytime that my team and I email them questions. They are also genuinely appreciate unfiltered feedback from their customers. Their positive attitudes and attentiveness, specifically throughout our onboarding process, has been instrumental to our success in implementing GG. We did NOT feel like we were left on our own during this process.
The biggest gain for us has been being able to get our QMS up and running from scratch in less than 3 months. It is reassuring knowing that the system helps us to be ISO 13485 and 14971 compliant. We have found GG to be very useful in documenting our design controls and risk matrix. We really like how the system allows you to connect these areas.
