Opiniones de Greenlight Guru

A god-send of a QMS

Comentarios: 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.

Puntos a favor:

With GG, it is structured and organized to not just allow compliance, it promotes compliance - meaning using the software as it is built easily documents for product design/dev and ongoing quality req'ts. It's easy to use and navigate, quick to learn even for lay people, and makes our QMS regulatory headache-free.

Puntos en contra:

The team keeps making improvements, and I'm looking forward to a bit of a better structure to the large document repository. It is searchable, tagable, and sortable easily, but there are a few other ways that they could organize things so you can find something quickly.

Greenlight is the right choice for eQMS

Comentarios: 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.

Puntos a favor:

Building a maintaining a QMS system that is FDA compliant is far too complicated and expensive for an early stage startup. Greenlight gives you the tools and platform to follow a pre-determined process that allows you to get up and running quick, while also having the confidence that you are meeting required regulations. Team has always been super helpful with great customer support.

Puntos en contra:

eQMS can be complicated with lots of jargon. It does take a sustained push to become aquatinted with terminology and incorporate into you daily workflows.

My experience with Greenlight Guru

Puntos a favor:

I like how this platform has helped us streamline our compliance, enhance our product to market timeframes and has helped elevate our game

Puntos en contra:

It’s a little difficult to manage cross team collaboration within the tool

Terrible customer service despite being super expensive

Puntos a favor:

Good performance, good templates, comprehensive follow up for eQMS for med tech.

Puntos en contra:

Too expensive, terrible customer service and attention.

Good for the price

Comentarios: It was rocky hard to get help or support

Puntos a favor:

It was easy installation and pretty ok .

Puntos en contra:

Slow speed that’s about it tho I mean ..

Truly Turnkey, Great for new companies

Comentarios: 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.

Puntos a favor:

Using Greenlight.Guru, we were able to build a quality system from scratch quickly that met our needs without the headache of complicated set-up and configuration. This tool enabled us to go from nothing to passing our first audit with confidence and ease. Great tools to link design and risk with documents and approvals. The customer service was also great, and Greenlight helped build our knowledge of Medical Device Quality at the beginning of our company's life, allowing many of us to rise from inexperience to competence to near mastery of quality systems. Greenlight further offers an unparalleled user interface and intuitive tools that make using it a cinch for almost all employees at our company.

Puntos en contra:

Understanding best practices can be a bit challenging and time consuming given that there is one standard offering for all customers and customization is intentionally not available. Being a new company, Greenlight has grown with us. Some features that would have been nice to have earlier were developed and pushed during our use of the software, though it is clear that the product is maturing to meet the needs of its customers without sacrificing the ease of use.

Only eQMS geared towards medical devices

Comentarios: 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.

Puntos a favor:

Wow so many things - selecting/modifying roles/permissions, creating teams, personalizing profiles, tagging documents, grouping documents, adding/uploading w/ w/out a change order, creating/activating training events, tracking training events' progress/completion, automating/completing quality events (CAPAs, nonconformance, audits and customer feedback), adding/modifying/tracing design controls i.e., user needs, design inputs/design outputs, V & V and finally adding/modifying/tracing risk items and aligning them to the project. Customer service is quick to respond and Greenlight Guru is always taking suggestions for improvement, they have even implemented some.

Puntos en contra:

Just some suggestions for better functionality - ability to edit tags, ability to edit training events once activated or in the case the documents assigned to a training event changes, more user friendly quality event workspace, ability to easily change between full and lite users and vice versa.

Greenlight

Comentarios: Overall, I generally find Greenlight Guru to be a very user-friendly and comprehensive. with a strong focus on streamlining the product development process however, some might find certain features to be slightly complex for non-expert users, and may require additional training to fully utilize its capabilities.

Puntos a favor:

Helps companies streamline and automate their planning and quality processs

Puntos en contra:

Not always user friendly but once you get use to it is fine.

Guru is back

Comentarios: It went well enough for me to want to write a review on it

Puntos a favor:

Purpose-Built for Medical Devices, Intuitive and Easy to Use, and Customer Support & Training

Puntos en contra:

Limited Customization and it can be really pricy

User Friendly, Modern QMS System

Comentarios: 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.

Puntos a favor:

It is very modern and user friendly. Unlike most QMS systems which seam stuck in the 90s, they user interface is up to date with modern websites and is so easy to use it requires barely any training.

Puntos en contra:

The modules that are full fledged are wonderful. Modules like change management and training management need to be its own module and updated.

Medical device startup's experience

Comentarios: 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.

Puntos a favor:

The structure of the design control and risk management modules guide you through the process of documenting both. Especially great for someone who's never gone through these processes before.

Puntos en contra:

While it contains the core of what's necessary for a QMS, it lacks a lot of functionality that a larger business would need, making it likely that we'll outgrow it quickly.

Recommendation for Greenlight Guru as your medical device eQMS solution

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

Puntos a favor:

I like that this medical device software is built by medical device professionals and not just SW developers who don't even know what a medical device is! this SW is built to match the processes I have been doing now for over 35 years - document control, design control, capa, internal audits, etc. Both modules GO and GROW are on spot to meet the regulatory requirements.

Puntos en contra:

As with any SW we have to be methodical in our naming conventions as we load documents. Its all about setting rules as a company so that SMART naming is followed which makes the search mechanisms more effective.

Greenlight Guru for OtoNexus

Comentarios: 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.

Great solution for medical device companies

Comentarios: 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.

Puntos a favor:

The fact that it automates the process instead of just storing documents.

Puntos en contra:

It would be great to have email notifications when you have an assigned activity.

Good to Great

Comentarios: We really like using Greenlight guru and we believe that it is a service that all businesses in the medical industry should be using. However, when we signed on we were promised the addition of many various features. These features have not been added in the nearly two years we have been involved with Greenlight. I come from a software background and understand that things sometimes have to be placed on hold in order to fix more pressing issues. However, so far the additions that have been made have made greenlight more difficult to use rather than easier. We look forward to seeing some of the new features that have been promised to us in the near future.

Puntos a favor:

It is the only Medical device management software on the market. Also, it allows us to centralize our numerous documents and other design records together in one place.

Puntos en contra:

Limited functionality. We are still having to come up with our own solutions for numerous things that we believe were we able to use Greenlight it would immensely alleviate some of our work load.

Decent Doc control program that needs some improvement

Comentarios: Greenlight is excellent when you're still a young company and are able to grow with Greenlight. Lately, we would like more functionality with GL as our company is growing and features like training, and better/more flexible risk management matrix are needed. Hope to see GL grow, because their customer service is A+ and their advice and consultancy calls are also really good.

Puntos a favor:

Software is great for document control and for Design review and design freezes. Risk management functionality holds a lot of promise. Customer service is great.

Puntos en contra:

No training feature as yet and Risk management doesn't seem to work well for our style. Would like to see more flexibility on how that works. Document list doesn't load well in Chrome.

Best in the Biz

Comentarios: Greenlight Guru is a software that is paving a new path through a paper industry. With that, there will be bumps in the road from a functionality perspective. However, regardless of the bumps in the road the features are incredible and are only getting better as the team designs and iterates the software.

Puntos a favor:

Streamlines the quality process

Puntos en contra:

Still in its infancy and some features can be developed to make it seamless

Medical Device Startup - Go Platform

Puntos a favor:

Design Control and risk management features are very useful for maintaining your DHF documents and records. Design reviews and risk analysis processes are very intuitive.

Puntos en contra:

Document Management is weak when it comes to controlling revisions when updating or revising a document. Documents are revised outside the system and then uploaded. Collaboration between individuals must be coordinated to avoid multiple versions being circulated for editing. Training is accomplished by assigning tasks to individuals. Tracking training completion is done manually outside the system.

Great Software for a Small Company

Comentarios: We are a small, early-stage medical device company that struggles with all the usual small, early-stage company issues: minimal headcount, limited budgets but the same regulatory requirements that apply to anyone else in the space. Like many other companies in our position, we were using free or cheap tools to keep track of our design controls since we simply could not afford the systems that were available for purchase.
Enter Greenlight Guru. The system they presented was not only more affordable than anything we had encountered previously, but, being completely web-based, also did not require us to have any expensive IT infrastructure in order to implement.
The system is relatively intuitive, well thought out, and easy to understand both by someone entering information and someone reviewing the final product. We have already had several audits where this system has allowed us to quickly show that our design controls meet the regulatory requirements, which would have been much more difficult with our old, primarily manual methods of maintaining our records.
I would definitely recommend Greenlight Guru to anyone who has to follow design control regulations. It has certainly had a significant positive impact for us.

Great QMS Software

Comentarios: As a small company developing our first medical device, greenlight.guru was an incredibly helpful tool. The software doesn't just provide a means of storing and organizing documents, but also provides an interface for product development and project management that is very useful. Furthermore, the greenlight.guru team is nearly always available through the chat feature. On the rare occasions that issues do arise with the software, I've been able to get in touch with their programmers and resolved the matter within minutes.

Puntos a favor:

Easy to use and learn, integrates the entire Quality Management System into one interface.

Puntos en contra:

It was difficult to use on mobile devices and tablets. It's been a while since I tried accessing it from either of these types of devices and may have changed since, but it would be nice to be able to pull up documents on a phone every once in a while.

Worth Every Penny

Comentarios: Just a great streamlined software which allows the company to keeping moving forward in product development instead of "on" product development.

Puntos a favor:

The software is everything a company needs to prepare for FDA and ISO compliance in the documentation aspect.

Puntos en contra:

I cannot think of any comments about what I like least.

Outstanding Software and service

Comentarios: The customer service representatives are instrumental in the development of our startup. There knowledge and experience tremendously helped build a great QMS and risk system for our company to follow. Greenlight.guru should be used for any medical device and for in many other industries.

Puntos a favor:

Ease of use, good functions, literally digitalized the fundamental proceeds of engineering a great quality medical device, webinars, support.

Streamlined Quality System

Comentarios: I work as an R&D Engineer for a small start up company working on a medical device. Greenlight.guru has made the process of implementing a quality system very easy and simple. The biggest benefit I've found is the simplified organization that the service provides, namely keeping all documents in one place and not having to continually keep track of updating and compiling documents as progress is made. Great tool!

Great eQMS

Comentarios: I've had a very positive experience with Greenlight. It has saved a lot of time and headache for our company and the support is exceptional.

Puntos a favor:

Organized, easy to use, eliminates burden of using paper.

Puntos en contra:

Sometime the UX is a bit confusing. Just takes time to get used to.

Greenlight.guru is amazing

Comentarios: The staff at greenlight.guru are extremely knowledgable and helpful. They onboard you, teach you how to use the software, and help navigate the intricate, and complicated, world of QMS for medical devices