Greenlight Guru Reviews

As a new medtech company with many different product and differing product regulations, we are pleased to have Quality Management as one of our easiest tasks - which is rare to say. The team is fantastic and abundantly helpful, the system is quick to learn and easy to use, and the support you get standing the system up from scratch if you don't already have a system in place is great. We needed Quality "handled" so we could focus on the trickier parts of our company - Greenlight Guru was and is that perfect solution.

We evaluated multiple eQMS platforms, we went with Greenlight due to functionality, ability to scale as we grow, and the extensive / pre-existing documentation that we could leverage and tailor to our needs.

Greenlight Guru was a colossal disappointment for our company. We signed a 2-year agreement, expecting a quality product and decent service, but were thoroughly let down. Their platform underdelivered at every turn: clunky, counterintuitive, and nowhere near as efficient as advertised. After just 3 months, it became clear that Greenlight Guru was doing more harm than good, and we decided to stop using it altogether.

Despite our dissatisfaction, Greenlight Guru insisted we pay for the full contract term. Instead of trying to remedy the situation, they pushed us into a drawn-out and tense dispute that ended up in collections—something we've never experienced with a vendor before. Their rigid stance, complete lack of empathy, and unhelpful customer service made the entire ordeal a nightmare.

Save your time, money, and sanity. The product is bad, and the service is worse. Look elsewhere if you're in the market for quality, because Greenlight Guru falls painfully short."

Greenlight.Guru has allowed us to, from a very young, inexperienced stage, build from scratch an easy to use and comprehensive quality system that has passed external audit with ease. The customer support, user interface, and turnkey solution offered by Greenlight.Guru has exceptionally useful for us, and been the foundation for Quality Management at our company.

Great experience! Customer service is quick to respond and there is a help centre and greenlight academy with tutorials for quick reference. The traceability between design controls and risk elements is in itself worth it.

It was rocky hard to get help or support

The design and development module is truly the reason we purchased Greenlight. It is extremely simple, allows for easy/agile development and review and integrates risk.

Its an excellent tool with very good customer support.

Great support, easy to use.

Overall experience is great. As a small medical device company, I can't imagine keeping up with our QMS requirements without a software platform like Greenlight Guru.

I work for a small medical device startup, and we've used Greenlight Guru to set up our quality management system from day one. They've made complying with ISO and FDA standards for quality management straightforward, they keep adding helpful functionality to the system, and I look forward to continuing to work with them!

greenlight.guru is the perfect software solution for a medical device startup company looking to get a quality management system, compliant with both the FDA's and ISO's requirements, up and running. It also holds your hand through the design control and risk management process, which is especially valuable for a company without much experience going through these processes. We didn't need to hire a quality manager because of how helpful this software is, a fact that alone makes it worth the price.

We needed an eQMS system, and a method of tracking our project progress. Greenlight.Guru does that in a fluid, comprehensive manner - making my life far easier.

Ease of integration of design control with risk management is a breeze. No more tedious xcell spreadsheets!!

To date, GG has been an excellent partner in the implementation of an otherwise difficult system.

Overall the software is easy to use, but there are a few functionality that we wish were there, specifically:
- parallel approvers
- ability to attach redlines as part of routing (and then ability to publish clean copy); now it forces you to review redlines offline (not great since it gets lost in people's email, etc.)
- ability to reassign who can publish the document (if person who routed it is out and doc control/quality should be able to publish for them).
- ability to turn on email notifications if you have something in your inbox

It changed the way we documented risk related to the products. We streamlined our QMS and this helped us to come together as a team. Design reviews are easily assigned; change control tasks are set and executed - no more separate emails and phone calls to follow up - Greenlight does the nagging for you.

I am a consultant, working with OtoNexus, an early-stage medical device company, on the implementation of their Quality Management System (QMS). We advised them to consider deploying Greenlight Guru for this purpose, and they are in the initial stages of doing so. The Document Management features of the software appear to be thorough, well thought out and useable. Obviously, the flexible routing and detailed history features for document review and sign-off, and compliance with Part 11, are very helpful and key to the success of any medical device company's QMS. The tutorial on the Product Development module, which is based on 14971 risk management principles, seems like it will be an excellent tool. Unfortunately, the client is a bit behind in utilizing it, and wants some other project management features implemented that, frankly, are a bit beyond the scope of this type of software tool.

Customer support in general has been excellent. We have noted, however, that when product feedback is given, although the response to a question or issue is timely, there is often a defensive tone that comes across. An example of this was when there was a change to the software, which caused a conflict with login using a browser that had worked fine previously. Yet, we were not notified of this change, and once we found the issue, were told to update our browser. This software, like any other, is imperfect, and can and should be continuously improved.

Overall, my initial impressions are that this is an excellent software tool for implementing a QMS at a medical device company.

We have been using Greenlight Guru now for a few months and I note the following concerns:
1) There is no undo button - once editing in a screen if you accidentally change something there is no way to return to the original state - clicking the close button will save ANY change you make even incidental ones.
2) Loading time is ridiculous. Our software currently has fewer than 300 requirements total and loading can take a few minutes.
3) Traceability for risk doesn't yet work properly in terms of tracing right through to V & V
4) Workflow could be dramatically improved - so many clicks are required to create each requirement.
5) Sometimes you will create a requirement and it does not show up in your list until you refresh the whole list - which led to a couple of duplicate requirements being created and these then can't be deleted - only obsoleted.
6) Document signing order created huge headaches for us organizationally in efficiently getting documents routed and signed.
7) Users who were in the application at the time of document routing received no notification a document was waiting for them.
8) There should be a way to check all validation and verification test cases within a given protocol off at once. Individually checking them off as passed is a make-work exercise.
9) Search feature is totally brutal and sometimes will not find something as simple as the DI title (e.g. searching for DI-159 which exists does not necessarily return DI-159).
10) When switching between projects - window did not always update content - leading to editing the wrong requirements
11) No way to sort requirements except through tagging- no way to view a short list of requirements only with a given tag reliably since search function can't be relied on.

GreenLight.Guru (GLG) is a terrific tool that solves multiple issues - design controls, document controls, and compliance. Perhaps just as valuable is an unending stream of blog posts and educational articles from the GLG staff. Their goal is to help users of their software (and, frankly, just about everyone else) adopt best practices in medical device design and maintain compliance during the product development process and beyond. The system is not very intimidating, but still requires some sophistication to use properly. That being said, it enables a single person to do the work of several people, which is extremely efficient for a small or start-up company. My current "complaint" is that our GLG installation does not send email notifications about tasks or documents to review. This would be very beneficial.

GreenLight.guru has made implementing our quality system a manageable effort. We have likely saved half the effort and tens of thousands of dollars by using it for our first FDA submission.

We are saving a lot of time because it is so easy to link data to each other, and hence have the desired traceability. Furthermore, we are having a better overview of which requirements we have to verify and validate compared to our previous design matrix and risk matrix which was in Excel format.

Lastly we are saving time during change control in general, this can be done within a few minutes while uploading a new verison of a document, technical drawing etc.