Greenlight Guru as a Medical Device software solution

[okayfine]

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!

 

[QuinnM]

Hi okayfine,

I would not consider the Verse validation flakey. It’s 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

 

[Merlynmk20]

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

 

[okayfine]

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!

 

[Emma_F]

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.

 

[Merlynmk20]

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

 

[JoshuaFroud]

Ive been looking at greenlight guru and Mastercontrol. Still curious if anyone has actually used geenlight. I like the looks of it, but since its a start up I cant get any reviews. Anyone have any more feedback on a small company QMS?

I would warn you in advance regarding MasterControl, it is a very powerful tool but requires significant amounts of user input to maintain. I do not know the size of your business but we had to employ someone full time to ensure it stayed functional and had the expertise to implement the systems we needed within.

I, unfortunately, have no experience using Greenlight Guru though I did recently go through the demo process with them. It seems like a good piece of software, it is however incredibly prescriptive and offers no customisation at all so you must fit its way of working. I did not like some of the workflows it enforced and how they ran so I decided not to progress with it. It is also very expensive when compared to its competition.

 

[Sandra K.]

Hi! I recently had demo with Greenlight guru, but after I didn't get feedback or offer about their price. Can you help me regarding to this issue? Do any of you have information about? Thanks!

 

[JoshuaFroud]

Hi! I recently had demo with Greenlight guru, but after I didn't get feedback or offer about their price. Can you help me regarding to this issue? Do any of you have information about? Thanks!

Get in contact with the REP you were dealing with. With my experience, they were really responsive to emails.

 

[Sandra K.]

Thanks a lot!