Overview
What is Greenlight Guru?
Greenlight Guru is a quality management platform designed specifically for medical device companies.The platform is designed to help companies get safer products to market faster, simplify FDA and ISO regulatory compliance, and provide a single source of truth by connecting…
A great training system!
Greenlight Guru is a lifesaver!
Innovative Quality Management System Software
Great eQMS for Medical Device Startups
Awesome company with an awesome product!
Loving Greenlight Guru!!!
Glad we chose GG
Greenlight Guru is a great choice for a small or startup medical device company
Greenlight Guru - Ready, Set, GO!
Are you a medical device startup? Look no further, Greenlight Guru is the solution for you!
Greenlight Guru Review
Love GG
Greenlight Guru - Leaders in the Medical Device eQMS Space
Turbo Tax for medical device companies - take the pain out of Quality Systems
Awards
Products that are considered exceptional by their customers based on a variety of criteria win TrustRadius awards. Learn more about the types of TrustRadius awards to make the best purchase decision. More about TrustRadius Awards
Pricing
What is Greenlight Guru?
Greenlight Guru is a quality management platform designed specifically for medical device companies. The platform is designed to help companies get safer products to market faster, simplify FDA and ISO regulatory compliance, and provide a single source of truth by connecting…
Entry-level set up fee?
- No setup fee
Offerings
- Free Trial
- Free/Freemium Version
- Premium Consulting/Integration Services
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Product Details
- About
- Integrations
- Competitors
- Tech Details
- Downloadables
What is Greenlight Guru?
Greenlight Guru Features
- Supported: Design Controls
- Supported: Risk Management
- Supported: Audit Management
- Supported: Document Control
- Supported: Quality Processes (CAPA, Nonconformance, Customer Feedback)
- Supported: Analytics & Reporting
Greenlight Guru Screenshots
Greenlight Guru Video
Watch Product Overview Video
Greenlight Guru Integrations
Greenlight Guru Competitors
- Qualio
- ETQ Reliance QMS
- Arena PLM & QMS
- MasterControl
Greenlight Guru Technical Details
Deployment Types | Software as a Service (SaaS), Cloud, or Web-Based |
---|---|
Operating Systems | Unspecified |
Mobile Application | No |
Supported Languages | English |
Greenlight Guru Downloadables
- The Ultimate Guide to ISO 13485:2016 Quality Management Systems for Medical Devices
- The Definitive Guide to ISO 14971 Risk Management for Medical Devices
- Why Paper-Based Quality Management Systems are No Longer an Option
- 5 Do's and Don'ts When Choosing a QMS Solution for your Medical Device Company
- How to Manage QMS Changes Regarding EU MDR, IVDR & ISO 13485:2016
Comparisons
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Reviews and Ratings
(18)Attribute Ratings
Reviews
(1-15 of 15)- Change orders.
- Analytics.
- Flow charts for complaints.
- Flow charts for NCR.
- Documents could are hard to searched.
- It does not let you embed documents phases.
- Other departments can see superseded documents it should only allow the RA/QA department to see them.
The only less appropriate times is when you are looking for documents, it is not very intuitive and it takes a long time to do NCR's, complaints, and CAPA's because it does not let you just embed documents, instead you have to write every that you already have in the document.
A great training system!
- Simple interface
- Pretty decent UI
- Showing how many trainings are left
- Instructions on how to complete a training for the first time.
Greenlight Guru is a lifesaver!
- Document management.
- Design and development documentation.
- Quality Event Management, like training, CAPAs, and complaint management.
- It's a very general software, meant to appeal to many, instead of being customizable for each individual customer.
Innovative Quality Management System Software
- Design control.
- Risk management matrix.
- Training management.
- Change control impact assessments.
- Deviations.
Great eQMS for Medical Device Startups
- Design traceability
- Training management
- Risk management
- Occasional non-critical bugs (work isn't saved, documents load slowly, etc.)
- Some processes take too many clicks.
- Would love to see in-app support of more file types.
Awesome company with an awesome product!
- User friendly
- The best customer service in the industry
- Constant product updates
- Some features we'd like do not get implemented, but they are not major
- We'd like to see a few more integrations, especially with ERP systems
Loving Greenlight Guru!!!
- The new training module ROCKS
- Love the Audit module--better for tracking internal audits!
- The change order function is the best I have seen
- Periodic review of documents is an industry standard that is missing
- Would love a training matrix similar to the design matrix that links with procedures/work instructions
- Ability to modify or add parameters in the analytics function for better trending metrics
- Ability to modify or add to predetermined "lists" in CAPA, Audits, Nonconformance workspaces
Glad we chose GG
- Projects.
- Change orders.
- Quality events.
- The ability to fix a typo in the document description after publishing
- More functionality for lite users
We are also starting to use the product development and risk management modules for new product development. The built-in traceability matrix for design controls has taken some changes to our existing development process to implement, but as we get through the learning curve, we are really starting to see the potential.
- Change Orders are efficient and controlled, easy to route, and have good visibility
- Internal audits are well designed, and easy to use
- DHF management
- The search engine for locating documents can be improved
- While the consistent format across CAPA, non-conformities, and internal audits has benefits, the format does not always work in all cases
- Notifications and tasks can be overwhelming
Greenlight Guru - Ready, Set, GO!
- Greenlight Guru is designed specifically for medical device companies. In that, the platform helps meet FDA and ISO regulatory requirements.
- Greenlight makes document review and approval easy - navigating the system is intuitive.
- The Greenlight Guru team appreciates unfiltered customer feedback. They do take the voice of the customer seriously and will work to implement feature requests.
- Document editing must be accomplished by downloading and re-uploading.
- While the software is generally intuitive, users do have to really use the software to become proficient and to take advantage of its capabilities.
Are you a medical device startup? Look no further, Greenlight Guru is the solution for you!
- Excellent, knowledgeable (industry and software) support
- Continue to evolve as a company - add new features consistently
- Listens to customer feedback
- In line document editing (but I am told this is coming!)
- Ability to integrate with other systems (they are working on this I believe!)
- Lack of user license variety - only Full or Lite.
Greenlight Guru Review
- Customer service and support
- Easy to use
- Specific for medical devices
- Risk management during production and post-production phase
Love GG
- Change management.
- project management.
- Audits.
- Reminder notification.
- Personalization.
- Metrics.
Greenlight Guru - Leaders in the Medical Device eQMS Space
- Customer Service
- Work Flows
- Educational Resources
- Out-of-the-box SOPs/WIs
- Cannot currently upload more than one document at a time.
- Documents cannot be edited without downloading and re-uploading.
- There are some known bugs with some of the software (like the dates not displaying as they are input).
- Work flows are rigid and sometimes do not leave room to add additional information in an organized way.
Greenlight Guru is NOT currently able to be integrated into any ERP systems and therefore may be difficult for the Operations and Quality aspects of the organization if, for example, manufacturing is being performed in-house, and the ERP system is used to document all quality events. (In this case, it would be redundant to also document them in Greenlight Guru - although could potentially be useful to document investigation details.) Greenlight Guru also only allows documents to be uploaded one at a time, so for companies that want to convert their existing DHF or other QMS files into Greenlight Guru for completeness, this process could be incredibly time consuming.
- Greenlight Guru's cloud-based platform provides a very easy-to-use interface for all employees to participate in QMS activities.
- Greenlight Guru provides a superior technological solution to QMS management over a traditional paper-based system.
- Greenlight Guru's team is constantly updating and improving the platform to meet our needs as a medical device manufacturer. Their new capabilities, including employee training management, have been very valuable.
- Early on there were some bugs in the software, but Greenlight's team typically resolved the bugs quickly. Occasionally we still come across some bugs.