Innovative Quality Management System Software
June 16, 2022

Innovative Quality Management System Software

Anonymous | TrustRadius Reviewer
Score 8 out of 10
Vetted Review
Verified User

Overall Satisfaction with Greenlight Guru

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.
  • Design control.
  • Risk management.
  • Change management.
  • Streamlined design control process.
  • Our first design project created in Greenlight was cleared by the FDA on the first try in less than 3 months.
Greenlight is far superior in terms of Design Controls and Risk Management. It is more modern and easier to use. Greenlight is more expensive than GAS. The customization in GAS is nice and the ability to add custom impacts to any module has helped significantly with ensuring proper impact assessment when making changes. Greenlight Guru offers a task module that is very custom, but it relies too much on the human creation of tasks as opposed to more auto-generated tasks from Change Management or potential other uses like Supplier Management and Equipment Management. Given Greenlight has implemented so many positive changes in the last three years we have been using it, I am confident these will be addressed soon. The Design Control module made up for the flaws listed above.

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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.