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EQMS for small medical device company

#1
Hello everybody.
First of all, I hope you're well in this tough situation.
Stay safe and cheerful. We'll overcome this.
Since, I'm working from home and the business slow down, I have time to explore software for implementing the QMS according to ISO 13485 and FDA 21 CFR part 820.
Going paper-based isn't a good option. Especially when it comes to such situation. Also, the importance of staying in touch with the team is immeasurable.
Can anybody recommend the platform for implementing complete QMS with integrated chat?
I looked the Capterra and GetApp, but I'm so lost. Don't know from where to start.
Thank you in advance.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#2
Hi Teyla.
for a med Device company I recommend going with one of the established suites that offers Part 11 validation
In my last company, which was pretty small, I was considering these:
Q-Pulse
UniPoint
TrackWise
QT9

I was ready to move ahead with UniPoint but it was never funded by the company and then I chose to move on.
My new company has Q-Pulse and I'm liking it so far.
 

yodon

Staff member
Super Moderator
#3
In addition to what @ScottK posted, I've seen Verse and thought it was pretty good.

A recent discussion mentioned BPA Quality. It's built off of Microsoft's SharePoint and so you get Teams as a collaboration platform. That's the only one I know with integrated chat (I guess depending on what that really means).
 

Ronen E

Problem Solver
Staff member
Super Moderator
#5
If you search Elsmar for eQMS you'll find several threads with quite a lot of info in them.

In general, successfully setting up and breaking in a new eQMS (or a new QMS) will be labour-intense, require team collaboration and I doubt it can be done well remotely. Not sure that this uncertain time is a good one for such a venture.
 

James

Involved In Discussions
#6
I'm currently setting up iPassport in similar circumstances, I know similar organisations to mine that use it effectively. Feel free to DM me for specific questions, etc. I'm using WebEx to discuss system implementation with various groups of staff. Working ok thus far. Keeping the QMS platform separate to the implementation / chat tools is the way to do it I think... I'll be doing some training videos for staff too

James
 
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