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Greenlight Guru as a Medical Device software solution - Page 2

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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: 23
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
  Post Number #11  
Old 22nd August 2018, 03:22 AM
okayfine

 
 
Total Posts: 2
Re: Greenlight Guru as a Medical Device software solution

We are currently stuck between Verse, MasterControl, or greenlightGuru.
Small company, ten people, 3-5 people critical to QMS.
Maybe ten medical device, MDR-compliant products?
Current hybrid paper-based system has been a hassle between templates, and auditors asking for MS Excel spreadsheet validation.

Greenlight seems expensive, compared to the rest.
Especially hearing about these document control and on-boarding issues, they're the exact problem we were hoping to fix and a 4 year contract would be detrimental if they can't help us with those issues.

Truly interested in what they quoted you but I assume that's best not discussed.
I'm just happy they provide most of the validation or is that flaky too?

Thanks!
  Post Number #12  
Old 22nd August 2018, 09:57 PM
QuinnM

 
 
Total Posts: 23
Re: Greenlight Guru as a Medical Device software solution

Hi okayfine,

I would not consider the Verse validation flakey. Itís fairly straight forward. We did look into MasterControl, but they were about four times the cost. One difference between the companies is that MasterControl would come to our facility and configure the system. We configured the system with Verse support, so you will need someone to implement. This is how Verse is able to provide software at a low cost. Verse software is not perfect, and we added controls to resolve. If I was to implement again I would use Verse. Note this is for a small medical device company, less than 10 people. We went from a paper based system, to a software solution with 21 CFR Part 11 electronic signatures included.

Quinn
  Post Number #13  
Old 24th August 2018, 05:47 AM
Merlynmk20

 
 
Total Posts: 3
Re: Greenlight Guru as a Medical Device software solution

I would be interested in any feedback from anyone using this for design and development and risk management. We are looking to move from a paper based system and are considering greenlight guru
  Post Number #14  
Old 25th August 2018, 02:59 PM
okayfine

 
 
Total Posts: 2
Re: Greenlight Guru as a Medical Device software solution

Hey Quinn,

Thanks for that!
I was speaking of Greenlight Guru when I mentioned the validation. I've requested a call from Verse but have yet to hear back.

I wonder if Verse is more affordable than Greenlight.
Greenlight seems to be pumping out updates every 2 months so that's something to look forward to.

On the part of HR documents, I can handle scanning those as we only have a few employees.

Hoping Keldez can chime in on anything else they might have to say about Greenlight such as their training and onboarding guidance.

Thanks for all your help, feels great making a cove acc't after years of being a lurker.
Hoping I can contribute as much as I've learned but that will be a challenge!
  Post Number #15  
Old 28th August 2018, 08:07 AM
Emma_F

 
 
Total Posts: 2
Re: Greenlight Guru as a Medical Device software solution

I personally didn't use Greenlight Guru, but some of my colleagues did, and, some of them like it and some of them don't, which is normal. When you choose QMS software, essential is to know what your requirements are, and what do you expect from it. There are several must-have functions that every QMS software should have, like FDA CFR Part 11 and ISO 13485:2016 compliance, CAPA, Change control management, Document management, and control... You should have in mind that QMS software should work for you and that it should make your job easier. About a year ago I came across to QMS software named qmsWrapper. They are new on the market and pretty cheap, so no wonder I was skeptical at the beginning, but it turned out that I wasn't wrong to give them a chance. It met all our needs, and even more.
  Post Number #16  
Old 28th August 2018, 10:41 AM
Merlynmk20

 
 
Total Posts: 3
Re: Greenlight Guru as a Medical Device software solution

Thanks for the feedback. WE have a well established eQMS for document control and CAPA. What we are looking for with Greenlight Guru is the design control and risk management. If anyone has specific examples of using this or an alternative they are using for design and risk I would be interested in hearing the feedback
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