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Greenlight Guru as a Medical Device software solution
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Greenlight Guru as a Medical Device software solution
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medical device software, software (off the shelf), software tools (for qa statistics doc control etc.)
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  Post Number #9  
Old 7th August 2018, 04:47 PM
keldez

 
 
Total Posts: 36
Re: Greenlight Guru as a Medical Device software solution

We are currently using Greenlight Guru (as of 2 months ago; June 2018). I can say it's not all it's cracked up to be, but has potential.
Having previously made a Part 11 compliant QMS from a Confluence wiki, I can't say Greenlight Guru is any improvement, YET. Where we benefited from going this route is in preparing a full blown QMS in a matter of 2-3 months, whereas Confluence took me almost a year.
As of August 2018, they have a decent Design Control and Risk Mgmt module. I haven't used their CAPA/NCR or similar modules yet, so can't express my opinion there. Their Doc Control module is sub-par and not very intuitive - each document goes thru routing separately, then each gets the same change order attached at the end; very odd.
They may claim they have a way to automate Training, but this is not the case. It's basically an old paper scan in system, where they recommend each employee or dept mgr maintains training files (good luck!).
All in all, the software is expensive, but their development team is always kicking out updates and improvements, and I can see in the next year or two it being what us Quality gurus envision in our minds as an easy to use system with everything we need.

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  Post Number #10  
Old 8th August 2018, 05:08 PM
QuinnM

 
 
Total Posts: 19
Re: Greenlight Guru as a Medical Device software solution

In our business I implemented Verse Solutions. Is Verse perfect, no, but the value is extremely high. We looked at several quality management systems companies, but few had the validation support needed for our business. I do not work for Verse, but do recommend them for small businesses.

Quinn
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