Greenlight Guru - Leaders in the Medical Device eQMS Space
August 10, 2021

Greenlight Guru - Leaders in the Medical Device eQMS Space

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

Overall Satisfaction with Greenlight Guru

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.
  • Out-of-the-box validated workspace
  • Efficient work flows for documenting quality events and their investigations
  • Efficient work flows for documenting risk management and DHFs
  • Ability to approve documents electronically while remaining in compliance with the FDA's regulations for electronic signatures
  • Ability to store and update important quality documents, and have all employees have access and ability to self-train and document this training
  • On-demand customer service when issues are encountered
  • Has helped us to structure our QMS remediation efforts such that it's aligned with Greenlight Guru's implementation
  • Efficient workflows means that tasks can be tracked, so quality events are closely monitored and quickly investigated
  • Central repository for DHF/product-related documents allows for less mistakes made when referencing the newest, most updated form of the document(s)
We evaluated all 3 companies at the same time when we were "shopping" for an electronic quality management system solution. We spoke with other users about their experiences and received extremely positive feedback from 2 current Greenlight Guru clients. The clients highlighted the fact that they used Greenlight Guru in their audits, even with the FDA, and it went well. Greenlight Guru had comparatively more in-depth resources for SOPs, forms, and Work Instructions. Additionally, they have already made a name for themselves as general educators on Regulatory/Quality matters, as they run one of the few podcasts for the industry that are available. On the contrary, we had a very poor experience with the salesperson from Qualio, and had the impression that all documents would need to be manually created (couldn't just be uploaded), and there was a significant amount of work required to implement. (Conversely, the GG users said that implementation was quick, and only took a few months to get it up and running in a compliant manner.) For QT9, a current user gave a very poor review, and emphasized that it was not customizable, alerts could not be turned off, and that design controls were not part of the program. Since we required design controls as part of our QMS, we eliminated this product from our consideration.

Do you think Greenlight Guru delivers good value for the price?

Yes

Are you happy with Greenlight Guru's feature set?

Yes

Did Greenlight Guru live up to sales and marketing promises?

Yes

Did implementation of Greenlight Guru go as expected?

Yes

Would you buy Greenlight Guru again?

Yes

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.