Hacer D.
HD
Hacer D.
Senior Regulatory Affairs Officer
Small-Business (50 or fewer emp.)
"Strong QMS Linking, but Attachment Handling and Document Sign-Offs Are Time-Consuming"
3/5
What do you like best about Greenlight Guru Quality Management System?

That you can link NC's to CAPAs or CF's to CAPAs. That it is one system for the whole QMS. Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

For Procedures that have many attachments, it is very time consuming to check out every single attachment and upload it again within the system itself. Somethimes it takes 1 hour to upload all attachments to Greenlight Guru. Another problem for new attachments is that the revision number starts from 0 and doesn't match the revision number of the General Procedure anymore. We need to check out several times to match it to the GP which is very time consuming. We stopped doing it because of time efficiency reasons. We are also not able to electronically sign off documents within the system nor adjusting documents in the system as well. We are basically doing double work. We review and sign off in our server, add it in our document control list and then upload it to greenlight guru with a viewable pdf. The review round in the change control workspace doesn't even make sense for the procedures or work instructions. We face also difficulties sometimes with people being not able to download editable versions even though they have the correct rights. Review collected by and hosted on G2.com.

Holly Lawrence O.
HO
Holly Lawrence O.
Quality Assurance and Regulatory Affairs Manager
Small-Business (50 or fewer emp.)
"Simple, Clean, and Efficient eQMS for ISO 13485 Compliance"
4/5
What do you like best about Greenlight Guru Quality Management System?

GLG is very simple to use and administer. It requires very little configuration setup to create a powerful eQMS that is both compliant and efficeient.

Our company uses the entire platform in order to integrate ISO 13485 requirements and risk based thinking into all functions within the company.

Greenlight Guru is a clean platform that makes onboariding of new employees simple. Thirty minutes of training allows them to find documents and records quickly. Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

My only dislike is that the Risk platform does not have an option for "detectability". Completing a Risk Project in Greenlight and then repeating it within an PFMEA is duplicative waste. Therefore my company, as a contract manufacturer does not utilize the Risk Workspace at this time. Review collected by and hosted on G2.com.

Verified User in Medical Devices
UM
Verified User in Medical Devices
Small-Business (50 or fewer emp.)
"Greenlight Guru eQMS - year 5"
5/5
What do you like best about Greenlight Guru Quality Management System?

GG does software update validations for you, just need to review own system to look for and assess impact. New customizable change order impact assessment is nice because most changes in our system are for document changes, and frequently don't require risk assessment, have no product or process impact, etc. Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

Make the analytics more customizable. Some category options in non-conformance, CAPA and audit don't apply, end up using "other" - could make these customizable. Change orders track days open (which may be planned long projects), but tracking days beyond the planned due date would be useful. Review collected by and hosted on G2.com.

Amanda F.
AF
Amanda F.
Quality Assurance Manager
Small-Business (50 or fewer emp.)
"Fully validated and Operational eQMS system in no time. "
5/5
What do you like best about Greenlight Guru Quality Management System?

Green Light Guru makes it possible to go from having no quality management system or procedures to a fully functional system in such a short amount of time. They also offer pre-written SOP's for everything you need to be ISO:13485 compliant. They continue to come out with new products and are user friendly. Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

I would like to see better metrics reporting under the Analytics module. Review collected by and hosted on G2.com.

Aleksandra L.
AL
Aleksandra L.
Senior Director Consulting
Small-Business (50 or fewer emp.)
"Tailored Quality Management Workflows That Save Time—With Top-Notch Support"
5/5
What do you like best about Greenlight Guru Quality Management System?

Thoughtful user flows make the software tailored to quality management processes, which saves tremendous time and effort.

- Change management module allows for ease in evaluation and routing

- Training is straightforward and repeatable

- Design Controls are a dream! Every step allows for the right activities at the right time.

The software is highly available and we are notified of product releases well in advance, allowing us to rely on the software.

The use of AI is purposeful and does not take away from the core functionality of the software.

I feel like the software is well priced for the level of value and service we receive. The customer support is differentiating: we receive top notch support tailored to our developing needs. Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

I would appreciate more document control / library functions, like being able to rename files or put documents into folders. Filters and user groups do a good job of segmenting content, but for our use, we need a bit more file organization functionality. Review collected by and hosted on G2.com.

Anthony L.
AL
Anthony L.
Small-Business (50 or fewer emp.)
"Risk Management Powerhouse with Room for Improvement"
5/5
What do you like best about Greenlight Guru Quality Management System?

I use Greenlight Guru Quality Management System for controlling design, documents, and risk. I appreciate that it ensures user needs are transformed into verifiable design solutions and that risks in the design are appropriately mitigated. I particularly like the risk environment, especially how it triggers me to evaluate whether our verifications meet the risk control requirements. It helps me discover when a risk control should be a verification activity that doesn't yet exist, prompting me to create one. Greenlight Guru is also the primary way we control documents with respect to workflow and versioning. Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

One thing about the risk control environment specifically that could be improved, is better introduction of many-many relationships between columns. Currently, it is very repetitive to list the same control for many risk lines. Review collected by and hosted on G2.com.

Julie B.
JB
Julie B.
Small-Business (50 or fewer emp.)
"A Reliable Partner in Quality Management"
4.5/5
What do you like best about Greenlight Guru Quality Management System?

I've been using Greenlight Guru Quality Management System for over four years, and it's been a consistently valuable part of our quality and compliance workflow. I really appreciate how proactive their team is. They always keep us informed about updates, and their communication is clear, timely, and genuinely helpful. Whenever we have questions or need support, they've been kind, responsive, and easy to work with. The QMS itself is very comprehensive, doing a great job of helping us keep everything organized and under control. It's especially useful for managing documentation, maintaining traceability, and staying aligned with regulatory requirements. Over time, I've continued to learn more about the system and discover new ways to use it effectively, demonstrating how robust and well-designed it is. I also value the ongoing connection and feedback from their team, as it feels more like a partnership where they are invested in helping us succeed. I like that we can have everything on one platform, manage documentation, maintain traceability, and stay aligned with regulatory requirements, which is particularly valuable because we work in a medical device class one company where linking and tracing everything is crucial. The initial setup was pretty simple, especially with support from Greenlight Guru Academy and the help button within the software. Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

The only thing that I like less about the Greenlight Guru is when downloading the CSVs is not as clear as when we're seeing it on the platform itself. So it's a little tricky getting everything aligned into an Excel for filtering and seeing everything better. Review collected by and hosted on G2.com.

Verified User in Medical Devices
AM
Verified User in Medical Devices
Small-Business (50 or fewer emp.)
"Polished Performance and Onboarding, but Needs Better Filtering, AI support, and SEA time Support"
3.5/5
What do you like best about Greenlight Guru Quality Management System?

Performence is great, never a problem. But I feel personally risk management module need more work. Filtering feature would be really beneficial.

I have no problem regarding UI/UX but many of my teams would like to have the more traditional folder structure. I know this is already in the roadmap, but probably more people would prefer to work on this setting.

ROI can be a bit on the higher side, especially for pre-validation startups. GG is quite polished, but competitors are on the way. One problem for us is the user allocation is too small, both accounting full user and limited user. Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

Support/onboarding and integration felt really complete but I hope more support staff is allocated for the East Asia/ SEA region timezone. As of now its a bit hard to get support within our 9-5 work time.

AI/inteligence is not there yet. Probably more functionality that came with the API is good and an MCP connector might be interesting. Review collected by and hosted on G2.com.

Verified User in Manufacturing
AM
Verified User in Manufacturing
Mid-Market (51-1000 emp.)
"Good ISO compliance, traceability and docs in one place, but needs a more intuitive UI"
3.5/5
What do you like best about Greenlight Guru Quality Management System?

The more helpful aspect is that you can access all documentation and have traceability in one place. This also provides peace of mind that your system will be compliant with ISO requirements. However, Greenlight is not user-friendly at all, lacks a lot of intuitive format, and also modules such as risk, design controls, training and suppliers miss important features that represent a lot of users' time and effort Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

There are so many features that GG misses. The platform allows you to run a basic QMS, but when the organization escalates, the tools need to be able to let the organization grow. I think GG has a lot of restricted interactions, and from regular users, the outcome is always that it is not user-friendly. Review collected by and hosted on G2.com.

Verified User in Medical Devices
UM
Verified User in Medical Devices
Small-Business (50 or fewer emp.)
"Greenlight Guru helped us improve our quality management system efficiency"
4.5/5
What do you like best about Greenlight Guru Quality Management System?

I don't have new comments since we are no longer using Greenlight Guru, and I don't know what improvements have been made on the system since we stopped using it. Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

I don't have new comments since we are no longer using Greenlight Guru, and I don't know what improvements have been made on the system since we stopped using it. Review collected by and hosted on G2.com.