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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.
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