The system is relatively simple and easy to learn. Email notifications are helpful. Suitable for small companies that are not looked at carefully by regulatory bodies. Review collected by and hosted on G2.com.

For a medical device company, Greenlight is difficult to maintain in a way that is compliant to standards and regulations. Specific issues:

In Quality Processes, unable to route for approvals before final stage.

Nonconformance, Customer Feedback and CAPA worflows do not follow industry standard.

In Documents module, cannot add more than one file to an item.

Unable to customize.

The company has been non-responsive in attempts to provide feedback. Review collected by and hosted on G2.com.

Supplier and Training and Audit modules are efficient and useful for documenting all related documents in the same place. Review collected by and hosted on G2.com.

Search functions are not very helpful and precise. Review collected by and hosted on G2.com.

I like that the Greenlight Guru Quality Management System is user-friendly with an easy dashboard. I also appreciate the visualization of the design matrix and risk assessment, plus the document comparison. It's great for reviewing documents before approving and conducting audits. The agility of the system stands out too. Review collected by and hosted on G2.com.

I find searching files and adding comments on the development sections challenging. It took a year to deploy because uploading past information and updating all our GPs to include Greenlight Guru were quite time-consuming. Review collected by and hosted on G2.com.

Linking changes, NCMs, and audits makes our quality history easy to follow . Review collected by and hosted on G2.com.

It is another system to use outside our other ERP products. The price of Greenlight discourages me from trying to get all our staff accounts to view work instructions, so I end up using a separate system for that. But the medical product focus and easy linking outweighs that problem just enough. Review collected by and hosted on G2.com.

Document management -Change management and new training Review collected by and hosted on G2.com.

I think the audit function can be improved a bit. Review collected by and hosted on G2.com.

Good support and they added suppliers section which helps with management but this is kept separate from our other business systems which rely on it as a separate database. Review collected by and hosted on G2.com.

same thing lack of integrated pFMEA, folders is still not out and still need our MRP/ERP separate for business operations Review collected by and hosted on G2.com.

GG is the best eQMS for traditional medical device design and development (can't speak for software dev). We looked at many systems but would have had to keep our design matrices and risk in excel. The design workspace is build to ISO 13485 and allows you to link your design items to relevant documents and related risk items. You can document design reviews in software and print a simple design file. Risk is built to ISO 14971 and doesn't trap you into just FMEA. It incorporates harmonized IMDRF terms for hazards and harms and includes various regulatory codes, which is great for regulatory reporting. You can review and lock your risk analysis in a way that makes it easy for risk to stay a living "document".

You can view documents in app, which is surprisingly not a feature for many systems and a must have for me. Attributes and tags make it easy to organize and find documents.

Change management is flexible and allows you to route multiple documents at a time. Training is great, I can automate SOP training so nothing gets missed. The quality events could be improved but are workable and you can link audits to CAPAs to risk to documents which is great. Admin has got to be the easiest of any out of the box software and the support is world class.

If you want a super custom system, this probably isn't for you. If you need a quick and straightforward implementation and are happy with a system built for ISO 13485 and ISO 14971 take a look! We were mostly implemented in 3 months and fully implemented by 5 with everyone trained! Almost all of the users find it intuitive to join, train, and sign off on change and documents. Users that use it for quality events, design, risk, and admin were able to feel comfortable very quickly. Review collected by and hosted on G2.com.

Quality events are inflexible but are at least built to include CAPA requirements for med dev. Analytics is limited, but still can provide some valuable data. It would be great if there was an easier way to get signatures from external users (like suppliers) without inviting them into you system, but it's not hard to work around.

Biggest complaint is pricing. It may not be competitive for many teams. It's annoying to pay for extra projects. Review collected by and hosted on G2.com.

It has a great interface and the features with the new upcoming AI is really helping Review collected by and hosted on G2.com.

search functionality. Currently the search tool isnt as great and we need to access other documents to identify document name/number and then search on Greenlight. Review collected by and hosted on G2.com.

Addition of features such as supplier grouping have made the system more functional. Review collected by and hosted on G2.com.

It would be beneficial for them to add AI to the system which would greatly aid in the search function and retrieving relevant information. The current search function itself is not very good. Review collected by and hosted on G2.com.

Excellent server that offers the necessary training tools in one place. Review collected by and hosted on G2.com.

I don't dislike anything about it Greenlight Guru. Review collected by and hosted on G2.com.