EQMS solution (Greenlight Guru and Q-Pulse currently being explored)

[Shaun]

Hi all, I'm working in a young business and currently in the process of establishing the QMS. At present, all records are paper based and I am using Google Drive for controlled documentation so I can restrict access, etc. I'm looking to migrate to an eQMS this year as we are very spread out as a workforce and people travel a lot. Our solution needs to work on both PC and Mac too.

Any feedback on real World usage of the above tools, or other cost effective, intuitive solutions would be greatly received

 

[Marc]

Here's a quickie: Greenlight Guru as a Medical Device software solution

 

[Ronen E]

Given you have experience with Google Drive I would consider using Google Sites for building a Wiki-style QMS (I call it a "WQMS"). Totally free, cloud-based, should work with PC and Macs.

There are plenty of F/OOS Wiki engines out there, as well as other free SW goodies you might need in support.

Please buzz me if you want to build something together. I currently feel a WQMS is the way to go, and Google Sites seems the easiest solution if you don't mind being 3rd party/Google-reliant.

In a few words - I had some experience with GG and I wasn't impressed, except for their ticket responsiveness which was good most of the time.

Cheers,
Ronen.

 

[Shaun]

Hi Ronen,

Thanks for your response. The main reason I was looking to move away from the Google approach is that I need a part 11 compliant electronic signature for document approvals and training records. For a small team who work remotely a lot of the time, the paper system just isn't logical for us.

Do you know if Google Sites has the facility for e-Signature which is part 11 compliant?

Regards,

Shaun

 

[mihzago]

You could maybe use a third party digital signature software like DocuSign, but that usually requires converting documents to PDF, so I'm not sure if that would work for you.

 

[pziemlewicz]

I've used IMSXpress before, and liked their e-sign approvals and document histories.

The only downfall is that everything gets converted to .pdf, so you're having to go back and fill a form in Adobe when the functionality was originally in an XLS or DOC.

 

[Ronen E]

Do you know if Google Sites has the facility for e-Signature which is part 11 compliant?

Maybe, I haven't implemented it yet.
I'm quite sure that with the right combination of tech and procedural controls part 11 compliance can be worked out on any platform. Might take some creativity and determination though.
Cheers,
Ronen.

 

[mgadus]

Hey @Shaun,

Mike C. and the team at GG will be happy to answer any questions you may have. I thought it would be worthwhile to share two links regarding people that have been in a similar situation.

Google “Lucerno Dynamics Greenlight Guru” and click to first link to read the case study. Lucerno was in a similar situation in that their general purpose cloud storage solution couldn't be validated to Part 11 and they realized it was going to become a bottleneck for their team. Also if you google “pros cons of different eqms” and click the first link you’ll see how Sonavex is using Greenlight Guru.

We understand that selecting an eQMS provider that will expedite your time to market and set the foundation for scale is not an easy decision. Happy to do whatever we can to help you navigate the process.

All the best,

Mike Gadus
Greenlight Guru

 

[Enternationalist]

The main reason I was looking to move away from the Google approach is that I need a part 11 compliant electronic signature for document approvals and training records.

It's worth realising that electronic signature requirements are not necessarily tied up QMS Software. It is entirely possible to implement your signatures solution seperately - for instance, it is feasible to use embedded PDF certificates for this application.

I'd recommend actually looking at part 11. It's not all that long - you may get some ideas about how you can satisfy the requirements without having to purchase a new backbone for your entire QMS.

CFR - Code of Federal Regulations Title 21