Sharepoint for ISO 13485 QMS for small IVD company

EmilAndersen

Registered
Hi,

Does any of you have experience with using Sharepoint for a 13485 compliant QMS for a small IVD company?

We are looking into whether it would be possible to find a consultant who could be responsible for creating the overall structure of the QMS, rather than having one of our own employees to do it since it will take time in training.

If you know the right person or alternative solution please feel free to suggest.

Regards
Emil
 

William55401

Quite Involved in Discussions
There is a great deal of content on the Cove related to off the shelf eQMS solutions that may already have some level of validation by the provider. Typically, the customer only needs to do an IQ and then have a process for managing updates (validating changes). I would not advise using SharePoint as a solution. I am not aware of anyone with a validated 21 CFR 11 compliant QMS that relies on that MS platform. Here's a WL cite (a bit dated) for an org that did not validate it adequately.

https://www.ofnisystems.com/media/ucm173977.pdf
 
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yodon

Leader
Super Moderator
Regarding your consultant question, there's a forum for that. :)

SharePoint has some interesting features but there's nothing built in that would enable a 'turnkey' QMS support system. As @William55401 points out, there are a number of eQMS solutions, some very expensive, some not so bad. Realize that if you go with a solution like SharePoint, you'll be investing a lot of time building up the infrastructure. I think the tools are probably in place to build it up and make the system compliant (no e-signature capability, though). And also realize that with an eQMS system, you'll still likely need to invest some time in setting up workflows aligned with your company's operations.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
When I worked at the VA they partnered with a local university. They had asked me to develop a QMS based on 13485 using SharePoint. I was able to create a workflow for documents and set up permissions and revisions. We were also able to set up a trace matrix for DI to V&V reports. Beyond that, though it was a challenge.
 

gard2372

Quite Involved in Discussions
Emil,

We are in the process of rolling out our Enterprise wide SharePoint on our Microsoft 365 platform. I did compare many EQMS platforms (ETQ, HQMS etc...) from cost, QMS functions, scaleability, IT integration ease, ease of use and one that was made for quality people not just a bolt on module in an existing ERP platform that is not designed for quality people.

Being a small company, I recognize cost is a factor which is also why we chose BPA as the cost per user is relatively lower than my experience with larger platforms.

We've decided on implementing the BPA Solutions QMS app that rides on top of the SharePoint Platform. With our Microsoft 365 platform, we can easily manage workflows, responses etc... more easily as our entire communications platforms are Microsoft.

Software Validation with BPA Quality & Risk Management


(Not a paid consultant nor being compensated by BPA Solutions)
 

yodon

Leader
Super Moderator
Ooh, thanks for that tip. I'll look into BPA solutions. I work with a lot of customers in the small / startup / no funds category.
 

EmilAndersen

Registered
Thanks everyone for the input!

Emil,

We are in the process of rolling out our Enterprise wide SharePoint on our Microsoft 365 platform. I did compare many EQMS platforms (ETQ, HQMS etc...) from cost, QMS functions, scaleability, IT integration ease, ease of use and one that was made for quality people not just a bolt on module in an existing ERP platform that is not designed for quality people.

Being a small company, I recognize cost is a factor which is also why we chose BPA as the cost per user is relatively lower than my experience with larger platforms.

We've decided on implementing the BPA Solutions QMS app that rides on top of the SharePoint Platform. With our Microsoft 365 platform, we can easily manage workflows, responses etc... more easily as our entire communications platforms are Microsoft.

(Not a paid consultant nor being compensated by BPA Solutions)

Thank you very much for the suggestion gard2372.

I have now been looking into the BPA solution and it does indeed seem quite flexible. Have you started your work on the platform yet? If so how do you find it performing?

And how long did it take to set up?

Kind regards
Emil
 

nima65kh

Registered
Hi,
Thanks for the discussion on this topic.
I am also looking for a eQMS Solution/ Application and being a Start-up we're not looking for something fancy or expensive.
@grad2372 and @EMIL can you share your experiences with this BPA Solutions, if you eventually went ahead with them.

Our company need to be compliant to ISO 13485, ISO 14971 as well as FDA and Health Canada Regulations. Do you think BPA would work with them?
And my understanding is that BPA is kind of an AddOn working with SharePoint. Would also confirm how does that work?
 

mmasiddiqui

Involved In Discussions
Hi,

Does any of you have experience with using Sharepoint for a 13485 compliant QMS for a small IVD company?

We are looking into whether it would be possible to find a consultant who could be responsible for creating the overall structure of the QMS, rather than having one of our own employees to do it since it will take time in training.

If you know the right person or alternative solution please feel free to suggest.

Regards
Emil
I have experience transitioning and establishing ISO 9001:2015 using SharePoint site. It is a bad idea having external consultant do this job for your company. After the consultant is done, there will be very little ownership from your stakeholders internally.
It is not that difficult to work internally.
 
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