EQMS question - Implementing an electronic QMS to support ISO 13485:2016

[kymberly]

Hi,
I am investigating implementing an electronic QMS for our medical device class I company. We are a small organization. I have researched QT9 as well as Green Light Guru. Does anyone have any input as to the performance for either of these? What EQMS do you use for ISO 13485:2016?

thank you!

 

[Chalino]

I have worked with EnterpriseIQ modules for QMS. Our company wanted to use the same system for orders and inventory and QMS, and EnterproseIQ manages to do all that.
I have worked with companies that use SAP for their QMS.

 

[locutus]

QT9 is a decent eQMS management platform though it is not too tailorable. I have used this in the past and for a company less than 100 people with some strange forward processes, this works quite well - it is more tailored to smaller organisations.

I have not used Green Light Guru, so could not say.

My recommendation on a eQMS software is only two aspects: 1) download or use a demo of the program - but really USE the program. Make sure it does everything you want or need to to do. 2) Determine how much you want to spend on a eQMS - and don't forget the support !

There are many at least a dozen decent ones out there, but they all have their pros and cons and all are at different prices. So like any PDCA process (chuckles) you want to plan well in advance on a system you want. Rather than just trying to pick you - set out your specifications, expectations, and what you want the program to do.

 

[QuinnM]

Hi Kimberly,

Verse solutions works well for small organizations. I implemented several modules for our small medical device company. Over all it worked well maintaining a balance between cost and performance.

Quinn