A god-send of a QMS

Bewertet am 11.12.2018
Sarah K.
President & Chief Operating Officer
Krankenhausversorgung & Gesundheitswesen, 2-10 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Quelle des Nutzers 
5/5
Gesamt
5/5
Benutzerfreundlichkeit
5/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
5/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

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 des Softwareanbieters

von Greenlight Guru an 14.12.2018

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.

Truly Turnkey, Great for new companies

Bewertet am 6.1.2020
Vineet E.
COO
Medizinische Geräte, 13-50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Quelle des Nutzers 
4/5
Gesamt
4/5
Benutzerfreundlichkeit
4/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
4/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

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.

Greenlight Guru for OtoNexus

Bewertet am 1.12.2016
Grant J.
Quelle des Nutzers 
4/5
Gesamt
4/5
Benutzerfreundlichkeit
4/5
Eigenschaften & Funktionalitäten
4/5
Kundenbetreuung
4/5
Preis-Leistungs-Verhältnis

Kommentare: 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.

Antwort des Softwareanbieters

von Greenlight Guru an 17.12.2018

Hi Grant, thank you for taking the time to write your review of greenlight.guru.

You input, and the feedback from all our customers is very important to the continuous improvement of our software.

Since your original feedback on 12/1/16, we've evolved our internal release processes and documentation in order to assure changes such as this are better communicated with customers.

Thanks again for your feedback and partnership.

More functionality preferred

Bewertet am 15.11.2016
Dieu W.
Quality Manager
Medizinische Geräte, 13-50 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Quelle des Nutzers 
3/5
Gesamt
4/5
Benutzerfreundlichkeit
2/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
3/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

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 des Softwareanbieters

von Greenlight Guru an 14.12.2018

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.

Initial Review

Bewertet am 1.4.2019
Art M.
Chief Operating Officer
Medizinische Geräte, 2-10 Mitarbeiter
Verwendete die Software für: 1-5 Monate
Quelle des Nutzers 
5/5
Gesamt
5/5
Benutzerfreundlichkeit
5/5
Eigenschaften & Funktionalitäten
Kundenbetreuung
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

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

Vorteile: We set out to implement a QMS for our small Medical Device Company. To date, Greenlight Guru (GG) has proven to be an excellent choice. We are only a few months into the process but I see no problem in staying on track. Their support has been fantastic! We are ahead of schedule and I have been pleased with the quality of support we are getting. Our company has had a few false starts with consulting firms, GG is making the process enjoyable.

Nachteile: GG offers a package of procedure templates that make the job much easier. With that, the formatting and wording of the templates could be a tad more uniform. With that said, it is understandably difficult to make a universal set of templates that fit everyone's needs. I find the template package well done on that front.

Antwort des Softwareanbieters

von Greenlight Guru an 10.4.2019

Hey Art -

Our team greatly appreciates you taking the time to provide your feedback. We are thrilled to hear that our Customer Success team's Fanatical Support has jumpstarted your implementation process, while also making it an enjoyable experience.

We appreciate your feedback regarding our procedure templates, as well. Please feel free to share your ideas for improvement with a member of our team.

Thanks again - Glad to have you as a customer of Greenlight Guru!

Focus on the work - not the admin!

Bewertet am 29.5.2019
Dalene S.
QA Manager
Medizinische Geräte, 13-50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Quelle des Nutzers 
5/5
Gesamt
5/5
Benutzerfreundlichkeit
5/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
5/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

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 des Softwareanbieters

von Greenlight Guru an 4.6.2019

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.

GreenLight is the best product development software

Bewertet am 2.8.2019
Kevin N.
Process Development Engineer
Biotechnologie, 13-50 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Quelle des Nutzers 
5/5
Gesamt
5/5
Benutzerfreundlichkeit
5/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
5/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Vorteile: GreenLight team members are very responsive to concerns. The software itself is essential for any small-medium company hoping to get through the product development process and receive FDA clearance/approval.

Nachteile: I wish there was a training module. Training currently uses up a good amount of our time.

Great overall product

Bewertet am 7.5.2019
Kevin K.
VP
Biotechnologie, 2-10 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Quelle des Nutzers 
5/5
Gesamt
5/5
Benutzerfreundlichkeit
5/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
5/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: We are new to the QMS world and this software has been very useful.

Vorteile: Ease of use and very intuitive interface. Navigating the platform is very easy and functions such as uploading documents and routing are very easy to use.

Nachteile: Minor litle issues that seem to have been fixed in recent releases.

Antwort des Softwareanbieters

von Greenlight Guru an 4.6.2019

Hey Kevin -

Thanks for sharing your positive remarks! Our team is pleased to hear that our software has been useful for you and your team as you enter the QMS world.

Please feel free to reach out to us whenever you come across any minor issues or have other feedback that you would like to relay to our team.

Greenlight Guru

Bewertet am 11.3.2019
Ward B.
COO
Medizinische Geräte, 2-10 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Quelle des Nutzers 
5/5
Gesamt
4/5
Benutzerfreundlichkeit
5/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
5/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: The ability to properly and effectively manage our quality system and eliminate all paper documents.

Vorteile: The ability to organize all documentation and execute design reviews and risk management within one platform.

Nachteile: Navigation can be a bit difficult at times.

Great e-QMS software

Bewertet am 11.3.2019
Amrita B.
Quality Engineer
Medizinische Geräte, 2-10 Mitarbeiter
Verwendete die Software für: 1-5 Monate
Quelle des Nutzers 
4/5
Gesamt
4/5
Benutzerfreundlichkeit
5/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: Very engaging and great timely response by the customer success team!

Vorteile: Makes documentation easier! Love how its always updated with the current standards.

Nachteile: The risk management system and the search feature have scope for improvement.

Antwort des Softwareanbieters

von Greenlight Guru an 18.3.2019

Amrita -

Thank you for taking the time to share your positive feedback!

We are happy to hear that you are enjoying our advanced document management platform and its associated workflows that keep your QMS compliant with current industry standards.

We would love to hear your feedback about how we can improve out risk management and search feature. I plan to have someone from our Customer Success team reach out to further discuss how we can integrate your feedback into our ongoing advancement of the software.

Thanks again!

Great software to implement and maintain a medical device QMS

Bewertet am 5.11.2018
Jason C.
Project Engineer
Medizinische Geräte, 2-10 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Quelle des Nutzers 
5/5
Gesamt
5/5
Benutzerfreundlichkeit
5/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
5/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: 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.

Vorteile: The design trace matrix makes the development process very straight forward and easy to use. The ability to link anything to each DTM component, and to link the DTM to the risk management module is great as well. The document management and routing/approval features are also a great tool. We've been able to implement digital versions of most of our work forms, without the need to use third party document signature programs.

Nachteile: Sometimes there is a bit of a learning curve for the various modules that they release. It would be nice if a help/guide button was available for each to walk through the module step by step.

Antwort des Softwareanbieters

von Greenlight Guru an 17.12.2018

Hey Jason:

Thank you for the positive comments and feedback.

Glad to hear that the ability to Link Anything is positively impacting your Design Control/Risk efforts and that built in workflows with eSignatures are simplifying processes.

As it relates to your feedback on getting up to speed on how to use new functionality, know that we've heard you and are actively working on a solution to help you get up to speed on how to use new functionality and what's changed in app that I believe you will be pleased with.

Don't ever hesitate to share additional feedback like this with us by phone, chat, or email at customer.success@greenlight.guru

Medical device startup's experience

Bewertet am 15.11.2016
Matthew B.
Co-founder / CTO / QA/RA
Medizinische Geräte, 2-10 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Quelle des Nutzers 
5/5
Gesamt
4/5
Benutzerfreundlichkeit
3/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
5/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: 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.

Vorteile: 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.

Nachteile: 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.

Antwort des Softwareanbieters

von greenlight guru an 5.12.2016

Hi Matthew, we appreciate you taking the time to write your review of our software.

That's great to hear greenlight.guru has enabled you to delay the hire of a full time quality manager.

Per your comment regarding the feature set needed for a larger business, we'd love to hear your specific recommendations if you have them so that we can take them into account as we continue to execute on our roadmap.

You can reach out to us and provide your feedback directly to customer.success@greenlight.guru.

To date, we have several larger medical device companies with multiple products and hundreds of employees that are successful using the platform.

Great product, continuously improving!

Bewertet am 12.12.2018
Stephen P.
Lead Quality Engineer
Design, 13-50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Quelle des Nutzers 
5/5
Gesamt
5/5
Benutzerfreundlichkeit
5/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: 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.

Vorteile: Greenlight.guru successfully ties risk analysis to design controls, providing a method of reviewing all of the design or component by component. All of the associated documents can be linked to Design items, weaving in the entire story behind a particular product. I have not found a similar product, and have never seen a more dedicated team. Issues that I have encountered, they resolve in a thoughtful, forward-thinking manner.

Nachteile: In the early usage, there were difficulties finding the documents I wanted. They have recently added the linking functionality on the document side, which allow related items to be tied to each other.

Antwort des Softwareanbieters

von Greenlight Guru an 17.12.2018

Hey Stephen,

Thank you for the kind feedback. The team at GG is dedicated to assuring the success of our customers.

Glad to hear the linking functionality is benefiting your efforts. Additionally, I think you'll be pleased with upcoming efforts we are making to further simplify document management starting with the debut of Document Views in our December release.

Keep the feedback coming.

Recommendation for Greenlight Guru as your medical device eQMS solution

Bewertet am 23.10.2018
Penny N.
CEO
Medizinische Geräte, 2-10 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Quelle des Nutzers 
5/5
Gesamt
5/5
Benutzerfreundlichkeit
5/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
5/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

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

Vorteile: 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.

Nachteile: 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.

Antwort des Softwareanbieters

von Greenlight Guru an 1.11.2018

Hi, Penny.

Really appreciate your feedback and comments.

Did you know that all documents are assigned a unique ID when added now? Yes, there is still a need to apply some intelligence with document naming and description. Those attributes (regardless of system) are key.

Sleek Medical Device QMS Software with a great Team!

Bewertet am 4.12.2018
Tonia B.
Director, RA/QA
Medizinische Geräte, 2-10 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Quelle des Nutzers 
5/5
Gesamt
5/5
Benutzerfreundlichkeit
5/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
5/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

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 des Softwareanbieters

von Greenlight Guru an 14.12.2018

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.

Good to Great

Bewertet am 29.11.2016
Douglas P.
Manager of Operations and QC
Medizinische Geräte, 2-10 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Quelle des Nutzers 
4/5
Gesamt
3/5
Benutzerfreundlichkeit
3/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
3/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

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 des Softwareanbieters

von greenlight guru an 12.10.2018

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?

Great and Developing Document & Design Controls

Bewertet am 15.11.2016
Michael F.
Director
Medizinische Geräte, 51-200 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Quelle des Nutzers 
5/5
Gesamt
5/5
Benutzerfreundlichkeit
4/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
5/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: 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.

Vorteile: Easily allows for document control in a compliant system for medical device development

Nachteile: I like traditional interfaces with document lists that look like a "Window" rather than highly formatted presentations. Give me simple presentation.

Antwort des Softwareanbieters

von Greenlight Guru an 14.12.2018

Hi Michael, our team appreciates you taking the time to review our software and provide your feedback.

I'm happy to share that functionality for automated e-mail notifications are now available. Additionally, individual users can modify notifications to their liking.

Please don't hesitate to provide additional feedback. Our team is actively listening to the evolving needs of our customers as we develop new functionality.

Jeff Schwegman Review

Bewertet am 17.11.2016
Jeff S.
Director of Engineering
Medizinische Geräte, 2-10 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Quelle des Nutzers 
4/5
Gesamt
4/5
Benutzerfreundlichkeit
3/5
Eigenschaften & Funktionalitäten
4/5
Kundenbetreuung
3/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: Overall my experience is positive. I like having the User Needs through Design Validation all on one dashboard in front of me. The Risk Management section is a little cumbersome to use at this point. I'm looking forward to new modules like ECO etc.

Vorteile: The dashboard showing User Needs; Design Inputs; Design Outputs; Design Verification; Design Validation all on one screen. I also like the Doc control capabilities

Nachteile: Risk Management section is cumbersome to use

Antwort des Softwareanbieters

von Greenlight Guru an 14.12.2018

Hello Jeff, we appreciate you taking some time to write your review of our software.

Your feedback regarding the risk management module has been heard and we believe you will be very excited about the changes coming with our risk 2.0 release.

As it relates to your feedback regarding automatic notifications, we are pleased to share that this functionality is now available to further enhance your team's experience when routing documents through approval workflows.

Glad to hear your overall experience has been positive and look forward to delivering on your feedback regarding the risk matrix.

Diabeloop_MChassouant feedback

Bewertet am 29.11.2016
Marion C.
quality and regulatory engineer
Medizinische Geräte, 13-50 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Quelle des Nutzers 
4/5
Gesamt
4/5
Benutzerfreundlichkeit
3/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
3/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: It is currently difficult to rate your system for me because Diabeloop managers decided not to use all fonctionnalities included within Greenlight-guru. If I may suggest something, I would like to have a less sensitive search system. Because right now if I don't know the exact name of my document, the search system will not detect it!

Vorteile: electronical signature and the fact that my document is blocked one published.

Nachteile: I would like to be able to put my document in file, not only have routing, published etc etc but QMS, DHF etc etc. I know I can do it with the search system but then I need my documents to have many tags...

Antwort des Softwareanbieters

von Greenlight Guru an 14.12.2018

Hi, Marion -

Thank you for the feedback. A while back, we debuted robust search document search functionality to address the use case you described.

Glad to hear that your team has started collaborating and using the system more in 2018.

Greenlight Guru does what it says on the tin....

Bewertet am 15.11.2016
Lizzie W.
QA/RA Officer
Medizinische Geräte, 13-50 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Quelle des Nutzers 
5/5
Gesamt
4/5
Benutzerfreundlichkeit
4/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
5/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: Green light Guru has been an invaluable resource not only in the set up an electronic QMS but in the advice available in the form of webinars and podcasts and someone who is new to the world of Quality and Regulatory requirements.

Vorteile: Aesthetically pleasing as well as practical and easy to use.

Nachteile: The risk and design modules have been difficult at times to use - the risk matrix is not easily maintained as a living record, e.g when a risk is mitigated and the scoring reduced.

Antwort des Softwareanbieters

von greenlight guru an 5.12.2016

Hi Lizze, thank you very much for taking the time to review our software.

We're glad to hear we've been able to live up to the promises made through our website and marketing.

Your input, and the feedback we receive from all our customers is very important to us. That being said, we appreciate you comments regarding the risk matrix, and they have been added to our backlog.

Your feedback will be considered as we look to release our risk 2.0 module.

Great solution for medical device companies

Bewertet am 15.11.2016
Ross K.
CEO
Medizinische Geräte, 2-10 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Quelle des Nutzers 
5/5
Gesamt
4/5
Benutzerfreundlichkeit
5/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
5/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

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 des Softwareanbieters

von Greenlight Guru an 14.12.2018

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.

Great eQMS for small and mid-sized businesses!

Bewertet am 15.11.2016
Ryan S.
CEO
Medizinische Geräte, 2-10 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Quelle des Nutzers 
5/5
Gesamt
5/5
Benutzerfreundlichkeit
4/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
5/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: We've been using Greenlight.guru for the better part of a year now and it really simplifies quality management. It's very easy to get all of our team on the same page and effortlessly trace various efforts through the system. The Greenlight.guru team is one of the best I've ever worked with. They bend over backwards to help you reach your goals. They are fantastic partners.

Vorteile: Ease of use, responsiveness of development team

Nachteile: The software is feature rich, but there are still a few features that would be great to see implemented. The Greenlight team takes feedback to heart and is generally quick to implement requested features.

Antwort des Softwareanbieters

von Greenlight Guru an 14.12.2018

Hello Ryan, thank you very much for taking the time to review our software.

We're happy to hear you've enjoyed working with our team and our software has been able to help you simplify your quality management efforts.

Our team takes your feedback to heart and believes you'll be pleased with all the functionality we've released in 2017 and 2018 centered around post market surveillance, multi-level design controls, advanced document management, and flexible review and approval workflows.

Please keep the feedback coming regarding how we can further simplify quality management for your team.

New Quality System

Bewertet am 9.10.2018
Valerie R.
Quality Manager
Medizinische Geräte, 13-50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Quelle des Nutzers 
5/5
Gesamt
5/5
Benutzerfreundlichkeit
4/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Vorteile: I love the ease of uploading documents and the automatic revision controls. Everything about the software is easy to understand and produces a digital trail for tractability.

Nachteile: I have not came across much of anything that I do not like about the software. If i ever have questions, I contact the customer service team and they walk me though it.

Antwort des Softwareanbieters

von greenlight guru an 12.10.2018

Thank you, Valerie, for your feedback regarding Greenlight Guru. It's great to hear how the document management features are helpful to you and your team.

Transition in progress

Bewertet am 15.11.2016
Evan S.
VP Operations
Pharmazeutika, 2-10 Mitarbeiter
Verwendete die Software für: 1-5 Monate
Quelle des Nutzers 
5/5
Gesamt
3/5
Benutzerfreundlichkeit
3/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
4/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: In general, this is a very good upgrade from the manual, Excel-based approach we had been using. The automation of trace ability is Huge! 1) As our matrices have grown, the interface slows to a crawl, slowing the flow of data input and evaluation.
2) The inability to separate use, design and process FMEAs, which may have different structures (including or excluding detectability $ having different "frequency" distributions), results in a missing the value of trace automation for the matricies that need to be handled manually.
3) The system doesn't have an efficient way to implement P1xP2 analysis of risk probability, and is harm-centric.

Vorteile: The relational database capabilities to link and trace. The CFR 11 and consistancy with 14971.

Nachteile: The structure is very rigid, which limits the ability to take advantage of some things in 14971 (like P1xP2 risk assessment) and some simply practical elements of design and development (like running separate and independent use, design and process FMEAs within a project.

Antwort des Softwareanbieters

von Greenlight Guru an 14.12.2018

Evan - Thank you for your honest feedback and being a great customer.

Automation of traceability is one of our customers favorite pieces of functionality.

Your feedback has been very important in the performance improvements we've made to assure the matrices perform well for customers such as yourself with larger amounts of data.

Additionally, we look forward to getting your feedback on future iterations of the risk matrix functionality.

Best in the Biz

Bewertet am 15.11.2016
Jordan M.
Director of Engineering
Medizinische Geräte, 2-10 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Quelle des Nutzers 
4/5
Gesamt
3/5
Benutzerfreundlichkeit
3/5
Eigenschaften & Funktionalitäten
5/5
Kundenbetreuung
4/5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

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 des Softwareanbieters

von Greenlight Guru an 14.12.2018

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!