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Was ist Greenlight Guru?

Greenlight Guru ist eine elektronische Qualitätsmanagementsoftware (eQMS), die von medizinischen Fachkräften entwickelt wurde und speziell auf die besonderen Bedürfnisse von Medizingeräteunternehmen zugeschnitten ist. Die umfassende, sofort einsatzbereite Lösung basiert auf den neuesten FDA- und ISO-Standards und Best Practices, die sorgfältig in jede Funktion innerhalb der cloudbasierten Plattform integriert wurden. Schließe dich Hunderten von anderen Medizinprodukteherstellern an, die mit dem Unternehmen zusammenarbeiten und verlagere deinen Schwerpunkt von reiner Konformität auf echte Qualität.

Wer verwendet Greenlight Guru?

Greenlight Guru ist eine ideale Lösung für Medizingeräteunternehmen, die Zeit und Geld sparen möchten, wenn sie ihr Produkt auf den Markt bringen. Zu den Kunden gehören Mitarbeiter mit QA-/RA-Aufgaben, Ingenieure und Führungskräfte gleichermaßen.

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Du bist nicht sicher, ob Greenlight Guru das Richtige ist? Mit einer beliebten Alternative vergleichen

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Bewertungen über Greenlight Guru

Durchschnittliche Bewertung

Gesamt
4,4
Benutzerfreundlichkeit
4,2
Kundenservice
4,6
Funktionen
4,2
Preis-Leistungs-Verhältnis
4,4

Nutzerbewertungen nach Unternehmensgröße (Angestellte)

  • <50
  • 51-200
  • 201-1.000
  • >1.001

Bewertungen nach Punktzahl finden

5
62%
4
28%
3
5%
2
2%
1
2%
Sarah
Sarah
President & Chief Operating Officer in USA
Verifizierter Nutzer auf LinkedIn
Krankenhausversorgung & Gesundheitswesen, 2–10 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

A god-send of a QMS

5,0 vor 6 Jahren

Kommentare: 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.

Vorteile:

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.

Nachteile:

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.

Antwort von Greenlight Guru

vor 6 Jahren

Hi Sarah, The team at GG greatly values your feedback and we appreciate you taking the time share your experience working with our software and team. Glad to hear you are excited about the upcoming enhancements to Advanced Document Management with with debut of Document Views in our December 2018 release. We strive to simplify quality management for medical device companies of all sizes, and welcome any future feedback or enhancements ideas.

Alex
CTO in USA
Medizinische Geräte, 2–10 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

In Betracht gezogene Alternativen:

Greenlight is the right choice for eQMS

5,0 vor 6 Monaten

Kommentare: 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.

Vorteile:

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.

Nachteile:

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.

Alcira
Therapist in Mexiko
Alternative Medizin, 51–200 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Good product

5,0 vor 4 Tagen Neu

Kommentare: Positive experience overall, would purchase again

Vorteile:

Products and services were excellent. I’m very satisfied.

Nachteile:

Ease of use ,could be more user friendly

Dieu
Quality Manager in USA
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

More functionality preferred

3,0 vor 8 Jahren

Kommentare: 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

Vorteile:

online

Nachteile:

very limited functionality

Antwort von Greenlight Guru

vor 6 Jahren

Hello, Dieu. Thank you for your feedback. We heard you, loud and clear. As a result of your feedback, we've added parallel routing and the ability to include redlines and mark-ups to review and approval workflows. Additionally, we've since enabled user level email notification preferences for you to better control the types of messages you'd like to receive via email.

Eudoria
Marketing Coordinator in Australien
Medizinische Geräte, 201–500 Mitarbeiter
Verwendete die Software für: 1-5 Monate
Herkunft der Bewertung

My experience with Greenlight Guru

4,0 vor 7 Tagen Neu

Vorteile:

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

Nachteile:

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

Vineet
COO in USA
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

In Betracht gezogene Alternativen:

Truly Turnkey, Great for new companies

4,0 vor 5 Jahren

Kommentare: 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.

Vorteile:

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.

Nachteile:

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.

Mel
QA in Kanada
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

In Betracht gezogene Alternativen:

Only eQMS geared towards medical devices

5,0 vor 4 Jahren

Kommentare: 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.

Vorteile:

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.

Nachteile:

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.

Rebecca
Asm in USA
Einzelhandel, 51–200 Mitarbeiter
Verwendete die Software für: Kostenlose Testversion
Herkunft der Bewertung

Good for the price

4,0 letzten Monat Neu

Kommentare: It was rocky hard to get help or support

Vorteile:

It was easy installation and pretty ok .

Nachteile:

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

Cassandra
customer service in USA
Gesundheit, Wellness & Fitness, Selbstständig
Verwendete die Software für: Kostenlose Testversion
Herkunft der Bewertung

Greenlight

5,0 vor 7 Tagen Neu

Kommentare: 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.

Vorteile:

Helps companies streamline and automate their planning and quality processs

Nachteile:

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

Samuel
Associate cashier in USA
Einzelhandel, 51–200 Mitarbeiter
Verwendete die Software für: Kostenlose Testversion
Herkunft der Bewertung

Guru is back

4,0 vor 7 Tagen Neu

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

Vorteile:

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

Nachteile:

Limited Customization and it can be really pricy

Chris
Senior Manager of QA in USA
Medizinische Geräte, 501–1.000 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

In Betracht gezogene Alternativen:

My GG Experience

4,0 vor 5 Jahren

Vorteile:

GG is hands-down the most user-friendly s/w I have ever worked with. The GG team has truly created simple easy-to-use workflows, while still offering complex functionality that conforms to the rigors of ISO 13485 standards. I love how you can link tasks, documents, investigations, and CAPAs. I personally love their DMS and Customer Feedback workflows. They're easy on the eyes, tell the whole story and allow for easy routing and approving to key stakeholders.

Nachteile:

GG's data analytics aren't very helpful and often inaccurate. The data they're tracking is rudimentary and seems to an after thought by the design team. Additionally, there is no reporting functionality in their Customer Complaints workflow. For example, if you're attempting to run a trend report for common root causes related to certain events, the s/w doesn't allow it. Therefore, I have to track everything outside of GG, especially for trend reports. Trend reporting and tracking is critical in any regulated industry, so I'm not sure why GG didn't think of this

Tonia
Director, RA/QA in USA
Medizinische Geräte, 2–10 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Sleek Medical Device QMS Software with a great Team!

5,0 vor 6 Jahren

Vorteile:

The system workflow is intuitive and easy-to-use right out of the box. We currently utilize the document management system and the module allows for quick uploads, document organization and ease of finding documents. The Greenlight Guru team behind the software works with you to meet your business objectives. Additionally, the have a strong customer focus and really listen to the voice of the customer.

Nachteile:

The search function can be a struggle at times; would really like the opportunity to filter further.

Antwort von Greenlight Guru

vor 6 Jahren

Hi Tonia - Thank you for sharing the positive feedback with our team. Our team is happy to hear that you value the turn-key nature of our solution for medical device companies. We strive to simplify quality for our customers and removing the burden of assuring documentation is compliant to regulatory standards is an essential piece in that effort. Please know that we hear your feedback regarding the need to find things faster within the system. I believe that you'll find the debut of Document Views in our December 2018 to be a starting point in helping you achieve this as we further enhance search and filtering functionality.

Dalene
QA Manager in Südafrika
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Focus on the work - not the admin!

5,0 vor 6 Jahren

Kommentare: 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.

Vorteile:

It sped up document control work flow and freed up the QA department's time to focus on validations and regulatory updates.

Nachteile:

We can't think of anything at this time.

Antwort von Greenlight Guru

vor 6 Jahren

Hey Dalene - Thanks for sharing your positive feedback about our software! It is great to hear that our software has freed up your team's time to focus more on strategic and value-add activities, instead of the manual labor of overseeing a QMS. If you ever have any questions or would like to provide us with more feedback, please do not hesitate to contact us.

Ross
CEO in USA
Medizinische Geräte, 2–10 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Great solution for medical device companies

5,0 vor 8 Jahren

Kommentare: 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.

Vorteile:

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

Nachteile:

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

Antwort von Greenlight Guru

vor 6 Jahren

Hello Ross, thank you very much for taking the time to write your review. We really appreciate your input and feedback. We're happy to hear greenlight.guru has helped save you both time and dollars on your first FDA submission. Additionally, I am happy to share that automatic email notifications associated with tasks you've been assigned are now available in the platform.

Douglas
Manager of Operations and QC in USA
Medizinische Geräte, 2–10 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Good to Great

4,0 vor 8 Jahren

Kommentare: 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.

Vorteile:

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.

Nachteile:

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.

Antwort von Greenlight Guru

vor 6 Jahren

Hi, Douglas. It is great to work with you and your team. Since you left this comment, Greenlight Guru has added a ton of post-market functionality to help you better manage quality events. Now that you are using these features, how are things going?

Laura
Product Development Lead in USA
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Decent Doc control program that needs some improvement

3,0 vor 8 Jahren

Kommentare: 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.

Vorteile:

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.

Nachteile:

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.

Antwort von Greenlight Guru

vor 6 Jahren

Hello, Laura. Thank you for the feedback. We have enjoyed working with you and your team. Did you know you can manage training activities in the software today? Regarding risk management, Greenlight Guru aligns with ISO 14971. And knowing that this standard will be revised soon, expect some updates to Greenlight Guru risk management workflow to continue to be in alignment with 14971.

Jordan
Director of Engineering in USA
Medizinische Geräte, 2–10 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Best in the Biz

4,0 vor 8 Jahren

Kommentare: 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.

Vorteile:

Streamlines the quality process

Nachteile:

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

Antwort von Greenlight Guru

vor 6 Jahren

Hi Jordan, thank you very much for taking the time to review our software. Awesome to hear you agree the software is only continuing to get better with every release. Per your comment regarding a CAPA feature set and others, this functionality was released as part of our Grow feature set in November 2017, which also included audits, customer feedback/complaints, and non-conformance. This sort of feedback is vitally important to us and is taken into consideration as we continue to execute on our roadmap. Don't ever hesitate to share additional feedback or improvement ideas with us via chat, phone, email at customer.success@greenlight.guru Thanks!

Vincent
Director of Quality Assurance in USA
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: 1-5 Monate
Herkunft der Bewertung
Quelle: SoftwareAdvice

In Betracht gezogene Alternativen:

Medical Device Startup - Go Platform

4,0 vor 5 Jahren

Vorteile:

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.

Nachteile:

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.

Sven
USA
Verwendete die Software für: Nicht angeboten
Herkunft der Bewertung

Great Software for a Small Company

4,0 vor 8 Jahren

Kommentare: 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.

Antwort von Greenlight Guru

vor 6 Jahren

Appreciate the comments, Sven. Let us know how we can continue to be helpful.

Jason
USA
Verwendete die Software für: Nicht angeboten
Herkunft der Bewertung

Great QMS Software

4,0 vor 8 Jahren

Kommentare: 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.

Vorteile:

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

Nachteile:

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.

Antwort von Greenlight Guru

vor 6 Jahren

Hi, Jason. Thank you for your feedback. Yes, accessing QMS information from Greenlight Guru on mobile devices and tablets is tricky. We are exploring how to do this as part of the product roadmap.

Chris
CEO in USA
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Worth Every Penny

5,0 vor 5 Jahren

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

Vorteile:

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

Nachteile:

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

Marsalas
Chief of Engineering in USA
Medizinische Geräte, 2–10 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Outstanding Software and service

5,0 vor 8 Jahren

Kommentare: 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.

Vorteile:

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

Antwort von Greenlight Guru

vor 6 Jahren

Appreciate the feedback, Marsalas.

Ryan
USA
Verwendete die Software für: Nicht angeboten
Herkunft der Bewertung

Streamlined Quality System

5,0 vor 8 Jahren

Kommentare: 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!

Antwort von Greenlight Guru

vor 6 Jahren

Hi, Ryan. Thank you for your comments. So glad you find the Greenlight Guru document management workflows helpful. Will you let us know if you have further questions and comments?

David
CEO in USA
Medizinische Geräte, 2–10 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Great eQMS

4,0 vor 8 Jahren

Kommentare: 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.

Vorteile:

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

Nachteile:

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

Antwort von Greenlight Guru

vor 6 Jahren

Hi, David. Thanks for the comments. We continue to evolve the UX to make it as intuitive as possible. Will you contact us if you still have questions about this?

Niru
Kanada
Verwendete die Software für: Nicht angeboten
Herkunft der Bewertung

Greenlight.guru is amazing

5,0 vor 8 Jahren

Kommentare: 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

Antwort von Greenlight Guru

vor 8 Jahren

Hi Niru, thank you very much for taking the time to review our software. We're glad to hear you've had a good experience working with our team navigating the world of QMS for medical devices.