Medical Devices Group

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October 2018
Henry Leung
Product at Striiv, Inc.
Pros/Cons of different eQMS systems

Hi Everyone,

We’re new to the FDA medical device, and we’re looking to implement an eQMS system into our workflow. We’ve looked at Greenlight Guru, MasterControl, and Enzyme. Was hoping to get some feedback from the folks here regarding the pros/cons of these products. Also, are there any others that you’d recommend?

Thanks.

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Posted by Henry Leung
Asked on October 8, 2018 5:43 pm
124 views
Private answer

Hi, Henry.

Let me know if I can be of assistance. Yes, I’m the founder of Greenlight Guru. And I want you to choose the solution that best meets your needs.

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Private answer

Hello Henry,

I have enjoyed our discussion on your companies specific needs and how MasterControl can assist. As we have discussed finding the right solution for your company needs today, as well as those needs that come with growth and expension is the number one priority. If there is any additional assiatance I can offer; I am here to help out in this process. I look forward to working with you and the team further. Have a great day!

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Private answer

Hey Henry,

My company, Sonavex, uses Greenlight Guru and I have been very satisfied. I’m not only pleased with the eQMS product, but the team has been an invaluable resource in supporting some of our quality and even regulatory decisions.

The main reasons we went with GG are:
– 21 CFR Part 820 and ISO 13485:2016 compliance is built in out the box, whereas a general purpose eQMS has to be configured to achieve compliance.
– Shorter implementation timelines and zero effort ongoing Part 11 validation.
– Fully integrated multi-level Design Controls and and product level Risk Management for medical devices. The living DHF has saved us a ton of time and we didn’t see that in other eQMS systems.
– Works well for complex devices with multiple components, even when dealing with a combination of hardware, software, and firmware.
– The team has strong medtech experience, and various members have counseled us on tough quality and regulatory related decisions.

Happy to dig in further if you’d like.

David

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