Greenlight Guru is a great choice for a small or startup medical device company
August 11, 2021

Greenlight Guru is a great choice for a small or startup medical device company

Anonymous | TrustRadius Reviewer
Score 9 out of 10
Vetted Review
Verified User

Overall Satisfaction with Greenlight Guru

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
  • CAPAs built in and tracked
  • Design controls and risk modules built into projects
  • Change orders
  • We've updated/ maintained our QMS more in the year that we've had Greenlight than in the previous 5 years combined; the efficiency of making changes is very valuable
  • The cost per full user and lite-user is not trivial, and to really get the most of the functionality you need to be a full user
  • We expect to accelerate product development once we get through our first couple of development projects
The interface and usability of Greenlight Guru seemed better, and the ability to make and control changes was easier.

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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.