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Greenlight Guru

Greenlight Guru

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…

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Awards

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Pricing

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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…

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Product Details

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 the management of all quality processes like CAPAs, risk, audits, document control, training, design control and more.

The vendor invites device makers across the globe to replace outdated paper-based and general-purpose legacy quality systems with Greenlight Guru to push beyond baseline compliance and achieve True Quality. A personalized demo is available at http://www.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

Screenshot of Design Control Spotlight: 
Documenting and managing Design Control traceability has never been easier. Perform Digital Design Reviews through flexible workflows to demonstrate compliance.Screenshot of Document Management Spotlight: 
Speed up reviews and approval workflows by keeping your records and procedures organized, up-to-date, and always accessible to the right people with role-based security.Screenshot of Risk Management Spotlight: 
Integrate Risk Management into all of your quality processes in a system that directly aligns with ISO 14971:2016.Screenshot of Post-Market Quality Events Spotlight:
Streamline your Post-Market Quality Activities to maintain full closed-loop traceability within your QMS.

Greenlight Guru Video

Greenlight Guru Integrations

Greenlight Guru Competitors

Greenlight Guru Technical Details

Deployment TypesSoftware as a Service (SaaS), Cloud, or Web-Based
Operating SystemsUnspecified
Mobile ApplicationNo
Supported LanguagesEnglish
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Comparisons

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Reviews and Ratings

(17)

Attribute Ratings

Reviews

(1-15 of 15)
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Score 9 out of 10
Vetted Review
Verified User
Incentivized
We needed an eQMS system.
  • 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.
Greenlight Guru would make it easier to have fewer documents lying around, and everything is within one system.

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.
Score 9 out of 10
Vetted Review
Verified User
Incentivized
We use Greenlight Guru to address company-wide training initiated by our Quality department. It's a great repository and electronic document management system for quality system and non-quality system documents. This system ensures everyone is up to date on their training and is trained to perform their daily tasks. It also keeps a record of everyone's training in case the company is audited.
  • 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 great for any company that wants to track or assign training. This system is also great for hosting quality system or non-quality system documents for the organization for employees to view or access at any time. This system is not great for billing, customer success, or sales-related tasks.
Score 10 out of 10
Vetted Review
Verified User
Incentivized
Greenlight Guru is our company's go-to for an eQMS. Using Greenlight Guru has made our processes much more efficient and allowed us to do away with signing off on and managing physical paperwork. Because of Greenlight Guru, our focus is more on quality rather than compliance, because Greenlight Guru makes the compliance stuff easy!
  • 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.
Greenlight Guru is well suited for taking your quality management system from paper-based to an efficient electronic and validated system. It's convenient to manage users, documents, content, training, and everything required by external regulations, and put those to good use to remain organized, compliant, and quality-focused.
Score 8 out of 10
Vetted Review
Verified User
Incentivized
Greenlight Guru is used at our organization as our Quality Management System. We utilize it to be compliant with ISO 13485 and FDA 21 CFR. We specifically purchased Greenlight Guru because it has a unique and innovative Design Control Module and Risk Management Module. As opposed to using a controlled Excel sheet, the design control module is thought out, compliant, and easy to generate the DHF.
  • Design control.
  • Risk management matrix.
  • Training management.
  • Change control impact assessments.
  • Deviations.
Greenlight Guru is a very revolutionary software that is the first software to my knowledge to revolutionize the creating of Design Matrices, Design History Files, and Risk Management. The other modules: Change Management, NCMR, CAPA, Training, etc have changed greatly over time and have improved tremendously. It could use some additional modules such as equipment management, supplier management, to make the software better. However, they are constantly adding improvements to the software, so I would imagine those modules will come within the next couple of fields. The software is not customizable at all. That does make implementation and adoption easy, but does limit functionality as many similar software have customization available.
Jason Troutner | TrustRadius Reviewer
Score 8 out of 10
Vetted Review
Verified User
Incentivized
We use Greenlight Guru for all of our Quality Management System needs, including design controls, document control, and risk management. Greenlight Guru allows us to develop our medical device products in a way that is compliant with requirements from the FDA and other regulatory bodies and is easily auditable for both internal and external audits.
  • 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.
Greenlight Guru is the perfect eQMS for smaller medical device companies, especially for users without extensive eQMS experience. I do not know if I would recommend it for larger enterprise customers. The most cost-conscious very early-stage medical device startups might be better off with a paper system, but I am very glad that we had the resources to start with Greenlight Guru from the beginning and did not have to make the switch.
Ryan Shelton | TrustRadius Reviewer
Score 10 out of 10
Vetted Review
Verified User
Incentivized
Greenlight Guru houses our electronic quality management system, which is essential for compliance in a highly regulated industry like medical devices. Nearly the entire organization has to use it, and it helps us streamline quality management, risk management, and design controls.
  • 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
Any medical device company that has entered the product development phase and needs to document their process should be a great candidate for Greenlight Guru. It may be less appropriate for software companies or companies that are not required to maintain compliance with ISO 13485 and other guidances and regulations in the industry.
Score 10 out of 10
Vetted Review
Verified User
Incentivized
We use Greenlight Guru across our organization and it replaced an outdated "clunky" document management system. Greenlight has significantly improved our productivity and quality management system.
  • 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
Greenlight Guru is an excellent choice for companies searching for an electronic Quality Management System which complies to ISO 13485 and FDA regulations.
August 11, 2021

Glad we chose GG

Score 10 out of 10
Vetted Review
Verified User
Incentivized
It is used across the whole organization. We now have a system where everyone can feel comfortable [using] and controlling the company documents.
  • Projects.
  • Change orders.
  • Quality events.
  • The ability to fix a typo in the document description after publishing
  • More functionality for lite users
It is user friendly. The training management has saved my team hours of time not having to manage it.
Score 9 out of 10
Vetted Review
Verified User
Incentivized
Greenlight Guru is being used to house our entire Quality Management System, and serves as our document control and records system. The change-order process for all QMS documents is also controlled through Greenlight Guru. We are also using it to create, track, and address CAPAs and complaints, non-conforming product, internal audits, and training.

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 seems ideal for small companies, and/or those in a start-up phase that need to start a QMS. We moved a mature QMS system for a small company from an old, legacy system to Greenlight, and it was relatively easy to do, but moving a large company QMS would be challenging. Moving old DHF and/or projects that are in process is challenging, and it is easier to start projects from scratch in the new software.
Score 9 out of 10
Vetted Review
Verified User
Incentivized
We utilize Greenlight Guru for document management across our entire company. The product addresses our need for a paperless system that ensures compliance with the necessary regulations and standards.
  • 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.
Greenlight is well suited during an audit. Auditors can be provided with limited access to the system and the user can tag specific documents to share with the auditor(s). Additionally, the speed and ease at which the documents (including historical documents) are available to an auditor is advantageous. No more running around trying to locate documents.

Score 10 out of 10
Vetted Review
Verified User
Incentivized
Greenlight Guru is a solution for the following: Document Management, Change Orders, DHF Creation, Traceability, Post market including customer feedback, audits, CAPAs, non-conformances. It is our source of truth for everything related to full lifecycle development of our products from concept to post-commercialization, complying to the applicable 21 CFR Part 11.
  • 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 is an excellent eQMS for any medical device start up. The solution itself allows any quality/regulatory professional to educate their team on compliance to the applicable regulations just by using the solution. It has allowed me to delay hiring of additional resources. Greenlight Guru also provides excellent training resources for this start up organizations that are not available with other eQMS as well as industry experienced experts (Gurus) that have been in the industry and now work at Greenlight using their talents to help support their customers and ensure they are not only using the solution correctly but maintaining compliance while using it.
August 11, 2021

Greenlight Guru Review

Murtuza Bohari | TrustRadius Reviewer
Score 10 out of 10
Vetted Review
Verified User
Incentivized
Greenlight Guru is used across the whole organisation. It addresses all aspects of QMS per ISO 13485:2016, ISO 14971:2019 and FDA QSR.
  • Customer service and support
  • Easy to use
  • Specific for medical devices
  • Risk management during production and post-production phase
If you are working with a medical device and would like to go electronic, then Greenlight Guru is the way to go.
August 10, 2021

Love GG

Score 10 out of 10
Vetted Review
Verified User
Incentivized
Greenlight Guru is being used to manage projects of the company and store information and document such as SOPs, FDA communications, and other documents. We use it as an audit (internal and external) and customer feedback platform. Changes to SOPs and other documents are managed through GG. QMS training is also managed through Greenlight Guru.
  • Change management.
  • project management.
  • Audits.
  • Reminder notification.
  • Personalization.
  • Metrics.
Greenlight Guru is well suited to make and track changes of documents as each document can be obsoleted and check out documents.
Score 9 out of 10
Vetted Review
Verified User
Incentivized
Greenlight Guru was implemented as an electronic quality system to replace the paper-based system at our company. It is being used primarily by the Regulatory/Quality and Product Development departments, but is also being used fairly regularly for the Operations and Marketing departments as well. The Finance department also has access as "lite" users so that they can access and sign off on relevant training. Greenlight Guru has helped greatly in the process to guide our quality system remediation efforts and helps to ensure that we are compliant with the US FDA Quality System Regulation. It also helps tremendously with keeping track of tasks, which helps to ensure that tasks are not left open for too long or indefinitely.
  • 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 well-suited for medical device companies. They have exceptional resources that are especially helpful for smaller, start-up type companies, including customizable SOPs, Forms, and Work Instructions, as well as countless other educational resources on focused topics like Risk Management or Auditing.
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.
Score 9 out of 10
Vetted Review
Verified User
Incentivized
We use Greenlight Guru across our company to manage our Quality Management System. We design and manufacture class 1 and 2 medical devices. Greenlight Guru has been an essential tool for managing our various QMS requirements including design control, document control, risk management, employee training, etc.
  • 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.
Greenlight Guru is great for small companies and start-ups developing medical devices. The platform relieves a lot of the QMS integration burden that new companies face. Think of it as "turbo tax" for quality control and regulatory compliance. Implementing a paper-based QMS system can be very time-consuming and ripe for error. Greenlight Guru makes it simple.
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