Greenlight Guru Quality Management Software Reviews & Product Details

The User Interface is very attractive and makes it easier to navigate. We like very much how everything can be linked, from Design Control Matrix to Doc Control to Risk Management, and how easy is to review data. We are very happy with all that we have learned with the resources from Greenlight about QMS, ISO standards, FDA regulations, etc. Our team is also already liking the new update that will allow us to properly document and review training sessions. Review collected by and hosted on G2.com.

Sometimes it is a little bit problematic that some team members are inactivated after not entering to the system. I am not sure if that can be changed or what. Review collected by and hosted on G2.com.

For our entire team, interaction with the quality system is paperless, real-time and traceable. Greenlight Guru continuously works on improving the system, listening to the customer feedback. It is obvious that the user experience for them is a high priority. Review collected by and hosted on G2.com.

I do not have something that I truly dislike about this system or find to be significant downside to using it. Like all things that improve and update the workflow there is learning curve for the team. Possible challenges that arise in that process are natural and to be expected. Review collected by and hosted on G2.com.

Greenlight Guru can offer packages that are nearly complete company quality systems with an ISO 13485 workflow. All of the big FDA requirements are met as well. The system can handle simple document control to sophisticated development traceability needs. It will also help pull together a compliant Risk Analysis. Support is better than anything I have ever experienced. The system is upgraded frequently and software validation is part of the package. Review collected by and hosted on G2.com.

There is not much to dislike. It is expensive, but you get what you pay for. It will not help manage your bill of materials like a PLM system will. Review collected by and hosted on G2.com.

Good process for signatures in sign offs for documents and design review. Easily linking design controls and print out a design control matrix. Excellent support team. Easy to upload documents. Streamlined change order process. Review collected by and hosted on G2.com.

Some of the usability for navigation is not ideal, can be hard to figure out how to get around the site and go back and forth between pages. I struggle with understanding which roles relate to which permissions. Would really like more integration for tracking training. The account / password reset is also challenging for a lot of users after being locked out. Review collected by and hosted on G2.com.

Greenlight Guru was a great choice as a start-up company where everyone works remotely. The design controls and risk management is what sealed the deal. As a SaMD, the integration with Jira was a plus. About 98% of the employees have never worked in a QMS and Greenlight was the most user friendly eQMS that we found. Review collected by and hosted on G2.com.

Even though Greenlight says they are a true full medical device QMS, they lack a training workspace. There is no easy way to track trainings, if training is late, and you have to come up with your analytics. Greenlight does not have a way to build quizzes within the system. Currently, we just re-vamped our training process, but there is a lot of work that Document Control needs to do outside of Greenlight in order to make sure trainings are done and in a timely manner. Review collected by and hosted on G2.com.

The prescriptive aspect to it.

As a small medical device manufacturer, we have many personnel who operate in multiple roles. With a self-managed QMS this can often lead, at least in our past experience, to holes in documentation and deadlines not met as the prioritization of work becomes messy.

With Greenlight Guru, you have the ability to assign those multiple roles to individuals within the software as well as adding different individuals to 'teams' to control the workflow even further; this, coupled with the color-coded importance of tasks means that each individual's unique dashboard not only clearly directs them to the work they need to complete, but also helps them prioritize their workload. Review collected by and hosted on G2.com.

Primarily, the risk analysis system.

While it does provide all the tools needed to complete a standard risk analysis; I find it is unique about the GLG processes in that it is actually more convoluted than doing it manually; it is worth noting at this juncture that I believe that there are discussions about overhauling this process.

This really boils down to how the scoring of harms is done. Currently, both the probability and the severity are tied to the harm - placing that harm on the matrix; which sounds reasonable.

However, in practice, the probability should be tied to the foreseeable event that would cause that harm - and there are often a great array of foreseeable events, each with different probabilities, that would all cause the same harm.

This means you have to duplicate the harm over and over again as you work through your analysis in order for it to land in the correct place on the risk matrix. This can get confusing when reviewing the analysis; even though the harms are uniquely identified, it is the titles of harms you're really reading. Review collected by and hosted on G2.com.

Locating a document within the system is easy and quick; setup of the system is intuitive and has a natural flow. Review collected by and hosted on G2.com.

I dislike the fact that there isn't a training module in which the system can keep track of training for each employee and send emails to read a revised procedure or something similar. Review collected by and hosted on G2.com.

The software is built on the specific standards required for medical device development. So it is very easy for someone with not a lot of experience dealing with the standards to get started on QMS. The entire eco-system around the software - the consultation, articles, webinars, and podcasts greatly help in the development of our product. Review collected by and hosted on G2.com.

Nothing in particular. The software keeps getting periodic updates based on user feedback. Review collected by and hosted on G2.com.

The posibility to have everything related to the QMS uploaded in ONE system - and the (when you learned) easy access for documents Review collected by and hosted on G2.com.

The system cannot search in documents for content - we have to write a very detailed information in "description" to have a chance to trace the record/doc in GG Review collected by and hosted on G2.com.

It is very easy to manage large amounts of data and have traceability on all of it. Especially during design & development, where many inputs have to be linked to outputs, verification(s) and validation(s). Furthermore, during the risk assessment the inputs and outputs, verifications and/or validations can easily be added as sources and controls to documents risk mitigation. Review collected by and hosted on G2.com.

It takes a long time to fill out the design matrix and risk matrix. I think the whole process of this could be optimized, but it is still way better than doing it in an excel sheet! Review collected by and hosted on G2.com.

I appreciate the intuitive interface that lets me keep track of documents, design control elements, and change all within a single platform. As a startup, we've used Greenlight Guru from day one of establishing our quality system, and being able to manage everything online has saved us from many headaches. The design control matrix in particular lets us note details about individual design control elements, link relevant documents, and manage risk, all within the same clean framework. The Greenlight Guru team is very responsive, and is constantly working to improve the regulatory compliance and user experience of the platform, and it shows. Review collected by and hosted on G2.com.

It does take some time to learn how the change control process works within the software, and it took us a little tweaking to figure out how to make the workflow work for us instead of creating more forms to fill. Some of the more recent updates have greatly improved the CO process, but especially at first it was somewhat redundant. Again, though, the Greenlight team has answered any and all questions we've had promptly, and we haven't had to work through this in a vacuum. Review collected by and hosted on G2.com.

The workflows explanation, articles and the accessible team support to resolve any issues or advance further learning Review collected by and hosted on G2.com.

Limitation on customizing the fields or attributes embedded in the system. Example, cannot create my own questions on the CO evaluation forms. Also, no training module that can auto populate the training needs with the release of documents. Review collected by and hosted on G2.com.

Beautiful interface, beautiful help guide, customer service availability, Design Traceability Matrix is much better with each update to link UN/DI/DOs, one stop shop for QMS compliance (pre and post market), amazing upload conversion from multiple formats to PDF, electronic approvals page automatically added to each document when published. Review collected by and hosted on G2.com.

Naming system (everything is DOC-###, no customization for prefixes), steep price point Review collected by and hosted on G2.com.

To link risk control and design items and to manage current version documents and obsoleted documents effectively Review collected by and hosted on G2.com.

When I click 'published' in document management, all documents including change management are shown. But I would like to look only documents except change management stuff. Review collected by and hosted on G2.com.

For a startup the most amazing feature once understood how to use: start the document in GLG as a record - not routed in the morning, and end the day with the document in GLG published as record - not routed. This will ensure you have file version history, and never ever again have to leave a document locally on your PC. Then once ready for routing simply change the document to record - routed. This workflow is just stunning. Review collected by and hosted on G2.com.

We didn't know that the above "What do you like best?" was even possible. I would argue the top feature is essential. Review collected by and hosted on G2.com.

The ability to use the linkages between documents/files is extremely helpful during audits. Very time-efficient! Streamlined and (relatively) uniform workflow for CAPA, AUDIT, NC, CF makes it easy to show the totality of our QMS and how items are related to each other. Review collected by and hosted on G2.com.

Change Management workflow could use some improvement (for example, reviewers can accept a Change Order without accepting the documents). Groups of users/roles can't be added to a document review as easily as they should. Review collected by and hosted on G2.com.

The software is easy to use, intuitive and workflows within it are updated in a timely manner to stay compliant with updated standards. It is very easy to train new employees on using the software as well. Greenlight.guru also has exceptional customer support, they go out of their way to help customers, respond to queries and are very receptive to feedback. Review collected by and hosted on G2.com.

We have had no issues with the software or the team, adopting the Greenlight QMS software has been a great experience. Review collected by and hosted on G2.com.

Helps us comply to ISO13485. Very easy to find relevant procedures and records Review collected by and hosted on G2.com.

In-program document editing would be greatly appreciated Review collected by and hosted on G2.com.

The step-by-step process and built-in software validation make the entire process a million times easier than it would otherwise be, as well as alleviating the anxiety we felt in the past during FDA audits. We especially like the post-market software, and our customer service, QA manager, and warehouse teams have done a great job implementing it. Review collected by and hosted on G2.com.

While it is a great software tool, getting our engineers on board was difficult. It was introducing a new platform into their workflow that they weren't accustomed to using. A lot of their work is documented elsewhere, and so importing that into Greenlight, even though it can be done simply as reference documents, still felt like redundant work for them. Review collected by and hosted on G2.com.

Makes it easy to stay in compliance without extensive prior knowledge. Review collected by and hosted on G2.com.

I find review & re-routing tedious tasks, and although it is necessary to retain quality I wonder if there are ways around it. Review collected by and hosted on G2.com.

They have medical device industry experience so know the requirements for an eQMS. Review collected by and hosted on G2.com.

Waiting for the training module, currently it’s hard to get reports. Review collected by and hosted on G2.com.

Greenlight Guru is constantly improving the software to meet user requirements along with the different regulatory needs. They take customer feedback and use it for continuous improvement of the system. Review collected by and hosted on G2.com.

Sometimes the validation package does is not released well in advance to allow the user to review the validation package prior to use. Review collected by and hosted on G2.com.

GG QMS offers an ideal balance between documenting detailed project information and representing that information in a clear, intuitive graphical format. Review collected by and hosted on G2.com.

Not a "dislike," but the traceability of risk information--individual Hazard=>Foreseeable Event=>Hazardous Situation=>Harm pathways is challenging at times. Different "pathways" to the same Harm must be represented by different versions of the Harm, even if it's the same fundamental Harm. GG's solution is good, just could be more flexible to account for complex risk analyses. Review collected by and hosted on G2.com.

The design controls and risk management matrices offer a seamless way to ensure all requirements and risks have been identified, verified, and/or mitigated. I love not maintaining multiple excel and word documents to create and update my design history file! The document control portion is also seamless and is easy to upload and search for documents. Review collected by and hosted on G2.com.

The complaint management system would be improved by offering fields to complete that are all viewable on one screen, with direct and relevant questions to answer. It is hard to consistently input complaints in the same way because the fields are not always intuitive and are on multiple screens. Review collected by and hosted on G2.com.

All of the advantages of an electronic QMS plus a more streamlined and logical way of thinking through risk management and the linking back to Design Controls. really allows the product development team to focus on what's really important and that's providing innovation and quality products that meet the regulations and the users needs making the most impact on the patients. Review collected by and hosted on G2.com.

Very minimal to dislike here. Their customer success team has been true to their title and making sure that we are doing the best practices in the software and if we have any dislikes they are heard and responded to in a timely manner. In our company we have multiple devices that share common requirements and it can be difficult to visually see what design controls are already tied to specific devices. Review collected by and hosted on G2.com.