Índice de contenidos
Greenlight Guru Review
The platform enables firms to bring safer goods to market quicker, simplifies FDA and ISO regulatory compliance, and offers a single source of truth by integrating the management of all quality processes such as CAPAs, risk, audits, document control, training, design control, and more.
¿Qué es Greenlight Guru?
The only quality management tool built exclusively for medical device from Greenlight Guru. On their Website they give you an abundance of resource with these key features your project can benefit by Navigating your QMS in an efficient manner. And recognize the impact of any change before the final Product. that will help you acheive your designed product to meet the medical device standards.
The Software has the following features:
|Design Control||With a single click, you can create sophisticated design control objects, link complicated configurations, and attach documents.|
|Document Management||Identify documentation during audits and inspections without having to track for stakeholders and documentation|
|Risk Management||The only cloud-based risk management system that is ISO 14971:2019 compliant.|
|Audit Management||High-risk findings should be escalated for inquiry, while low-risk findings should be monitored for recurrence|
|Complaint Management||Improve customer feedback management and supervision to achieve faster response times|
|CAPA Management||Detect and rectify quality issue patterns in real time before they become a regulatory concern.|
|Nonconformance Mgmt||Capture defect details such as component, quantity, failure type, and severity with ease.|
|Change Management||Before anything is implemented, define the scope, understand the consequences, justify the change, and record your decisions|
|Training Management||Know what training is currently underway, who has finished it, and review any previous data to confirm that the appropriate personnel got suitable training.|
How long does switching EQMS take with Greenlight Guru?
One of the key impacts of switching EQMS is the timeframe it takes to do. The average turn around is 12 to 15 weeks, however, with Greenlight Guru you get full support on their SaaS platform. The Transition time only take 2 to 8 weeks depending on the prioritized use.
What are the Key Benefits of Greenlight Guru Management software platform?
- Launch quickly
- Simplify product quality
- Easily manage risk
- Maintain end-to-end quality control between design controls and risk management, as well as post-market monitoring
- Complete visibility into their high-quality ecosystem
Can my Team benefit from using Greenlight Guru?
Yes, all team member will have assigned access that is 100% cloud based which gives you around the clock up time, collaboration, efficiency throughout your product’s lifecycle.
Can Greenlight Guru help with Validate the software to 21 CFR Part 11?
Yes, they do the validation for you. Aside from using Amazon Web Services, they established the compliance for 21 CFR Part 11 by IQ Protocols, Checklist, Full OQ/PQ for no addition cost to you.
Is my Industry specific Regulation aligned to FDA and ISO Standards with Greenlight Guru?
Yes, they help you comply with the Following:
- ISO 14971
- IEC 60601
- IEC 62304 FDA 21 CFR Part 820
- FDA 21 CFR Part 11
- ISO 13485:2016
Leadership isn’t buying into Greenlight Guru, what do I do?
The Medical Device Industry has also been affected by low quality and knock-off. And any company that’s looking to stand apart needs to know and understand their product with Quality control. Or there is the option to outsource at an additional cost.
So, the latter is to inhouse and gain dominance with Greenlight Guru by building a brand that not only becomes a house name, but increases the annual revenue to an additional 3-4%.
Quality Products are more expensive, & having the luxury to produce at their discretion, regardless of consumer demand.
What is Greenlight Guru Customer Support like?
When you Sign-up with Greenlight Guru, you get medical device industry experts who are available for phone, video conference, to help your Team with the Onboarding Process. Which is something that is always good to have.
There are additional Training resource on their website:
- Greenlight Guru Academy
- eBook & Guides
- Checklists & Templates
- Thought Leadership Articles
- Post on Their Job Board
Who else believes in Greenlight Guru software?
JMI Equity is a software growth Investment firm that gave $120 million to Greenlight Guru quality management software.
David DeRam said, ” We listened to the needs of the medical device industry and chose JMI Equity as a strategic partner because they are experts at achieving growth by putting the customer first”.
This commitment by both JMI Equity & Greenlight Guru is a bright sign to Greenlight Customers that their medical devices will bring better quality of life.
How much does greenlight guru software cost?
|Start-Up Kit||All-in-One Solution||Intelligent Solution|
|Design Controls (1 project)||Design Controls (Unlimited Projects)||Design Controls (Unlimited Projects)|
|Risk Management||Risk Management||Risk Management|
|Advanced Document Management (200 Docs)||Advanced Document Management (Unlimited Docs)||Advanced Document Management (Unlimited Docs)|
|Change Management||Change Management||Change Management|
|Task Management||Task Management||Task Management|
|Training Management||Training Management|
|Supplier Management||Supplier Management|
|CAPA Management||CAPA Management|
|Audit Management||Audit Management|
|Nonconformance Management||Nonconformance Management|
|Complaint Management||Complaint Management|
|In-Line Document Editing|