Greenlight Guru as a Medical Device software solution



Hi, I've been an Elmar Cove lurker for a while... :bigwave: thought it was time to jump in......just wondering if anyone has come across Greenlight guru as a Medical Device software solution, primarily for the Design and Development of Medical Devices, and complying with FDA and 13485.

Background....we currently manufacture and design medical devices in the UK. No current QMS software system in place, simply paper and electronic based system. Expanding rapidly and in need of more resource/help to keep QMS up to speed.


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Hi !

I recently heard about Green Light Guru, tough it is still a start up so I am not sure if they might be able to provide a full solution or easily implemented and tailoarable IT extensions.

From my knowledge, I have been looking into these other solutions, which seem to be already quite established:
-Polarion ALM
-PTC integrity
-Aligned Elements Ch.

I do personally favor both Polarion and PTC integrity. Depends on the complexity level of the solution you want to aim for.

Hope this helps !


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?


MiaQMS, I came across the GreenLight Guru product about six or eight months ago. I too worked with paper systems for many, many years before stumbling onto GreenLight. They have a nice, simple to use interface which is really intuitive. I really like it because it gives the benefit of everything that comes with a "digital DHF" (signatures, searchability, traceability, etc) without adding a lot of unnecessary overhead.

I would also add that although they are still a fairly new organization, I have been extremely impressed with how responsive they are and how easy it is to communicate with them. Also, even though their original product was focused more on the development side, I know that they are real close to releasing an aftermarket module that should tie in quite nicely with their development tools.
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I personally have not used Greenlight Guru's application, but if you are looking for an eQMS solution there are a myriad of options out there. My own personal opinion is there are two things to look at 1) if it fits your organisation and expectation and 2) cost.

As there are Windows users and Mac users, same holds true for eQMS systems - the look, feel, functionality, tailorability (not really a word), expansion, etc., are all key considerations. If they have a demo, definitely try those out first to get the feel for what the application can do for your replacement hard copy information. And then of course how much does it cost :).


I just wondered if there are any recent updates on this thread?
We are looking for an eQMS system, ideally with digital sign-off of documents and an organizational structure that would allow 3rd parties to upload docs directly without visibility of the entire documentation scope.
Because we are working with several subcontractors, having a snapshot of document progress would be handy (rather than keeping this information in excel).
Anyone have some useful feedback?


We had excellent experience in using Google Drive with Google Office for documentation control. Real time collaboration on editing and review of documents is excellent. The access rights - no access, read only, read write - can be controlled at a folder and document level. So appropriate controls can be put in place for access within and outside the organization.

For digital signatures within the organization, the Adobe PDF certificate based signatures worked well.


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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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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.
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