Interesting Discussion Using a Wiki to implement a Quality Management System (QMS)

[Ashley]

I have not found any referenc

3) Has anyone tried M-Files for QMS purposes?

e to M-Files on this website

I just saw your comment, you are the first one that mention this software (M-Files). Did you get the answer on this question?
Or maybe you already chose your eQMS. If that is case, could you recommend me software? I'm looking QMS software for ISO 13485 standard.

 

[Jeffbbt]

I just saw your comment, you are the first one that mention this software (M-Files). Did you get the answer on this question?
Or maybe you already chose your eQMS. If that is case, could you recommend me software? I'm looking QMS software for ISO 13485 standard.

I am still working to Implement M-Files. It seems no one on this forum has tried it yet. For Roger, it seems like it would be quite interesting.

I evaluated Wikis, and many other eQMS software packages - extensively. All evaluations need to be taken with a grain of salt though, because you can really only know how well something works until after you have it perfectly established!

I chose M-Files because we are in a similar organization to Roger, where we have many clients generating a ton of data. I wanted a Document Management System that could support an eQMS. This is accomplished in M-Files through Meta data, which basically tags all your files with the relevant info you want (Project name, client, Author) and then processes the files through workflows and automatically assigns reviews, permissions, etc. This is great for controlled quality docs but also business and operation docs.

The basis of M-Files (without the QMS) is to generate 'virtual' folders based on metadata. For example, I can create a folder that shows all my Clients. Or a Folder that shows all my DHR relevant files (and further sorted by client etc), or a folder for all my project files.

Take a look at the videos. I would recommend looking or the Compliance Kit video that is on Youtube (its hard to find on their site).

There is a caveat - it takes a lot of work to setup. I have been chipping away at it, but mostly being slow due to some customizations I wanted put in, and also validating it 'prior to initial use'. That being said - I dont think it is any more work that setting up a comprehensive wiki, sharepoint, or any other software. All these software packages need to be implemented for your particular organization...

 

[Jane's]

Excellent thread. One thing i was hoping to find was a comparison Confluence vs SharePoint - pros and cons of the two (other than the fact that SharePoint is a paid platform). If anyone have any thoughts on this, please post them.

From what I can gather - Confluence has part11 compliance capability through Comala Doc Management e. signatures feature while SharePoint, presently, does not. Could anyone confirm this? Thanks.

Here is one: Confluence vs. Sharepoint | Process Street | Checklist, Workflow and SOP Software and i wonder if anyone would like to add their 2 cents. A word of warning on the linked content - it's a colorful read.

 

[Jane's]

A belated question for those who transitioned to wiki for their doc management, how does wiki help (or not) your eCTD regulatory submissions?

 

[rogerpenna]

I am proposing my organization adopt XWiki.
It looks ready to use after a simple install using Docker and has plenty of features.

It allows creating templates, including templates that work as apps with different field types, like a field to add a date, or text, choice list, etc, etc.

It has lots of macros to insert in documents, like livetables, all sort of media, Diagram Drawing (inside the document, not elsewhere and pasting image), etc.

Still trying to understand some stuff... and how I can do it in XWiki.
Just read the whole case from Geometrica from the OP, gave me lots of ideas


Oh, and it's FREE, OPEN SOURCE, always a plus.

 

[eboelen]

I am proposing my organization adopt XWiki.
It looks ready to use after a simple install using Docker and has plenty of features.

It allows creating templates, including templates that work as apps with different field types, like a field to add a date, or text, choice list, etc, etc.

It has lots of macros to insert in documents, like livetables, all sort of media, Diagram Drawing (inside the document, not elsewhere and pasting image), etc.

Still trying to understand some stuff... and how I can do it in XWiki.
Just read the whole case from Geometrica from the OP, gave me lots of ideas


Oh, and it's FREE, OPEN SOURCE, always a plus.

We have tried XWiki, but it didn't work for us. Then we found Confluence, which is not open source, but very easy to use. I built our entire QMS for ISO 13485 and got it certified. Moreover as a Wiki, it became our entire knowledge-base, so our employees used it every day (auditors like that)!

 

[eboelen]

I see I'm quite late to the party, with the first post in this thread dating from 2009!
However, at my former medical device company, we performed a big quest on finding the right eQMS for ISO13485. Finally it was our IT-guy who said "what your looking for sounds a bit like Wikipedia".
In hindsight it was one of our best business decisions to use a wiki for our QMS! We settled for Confluence and it worked brilliantly for us. I built our QMS from scratch and we got it certified to ISO13485:2016. In parallel Confluence became our entire knowledge-base and it is very efficient to find information/documentation (no need to ask your colleagues where on the server to find a specific document!). The shared meeting note is also really powerful to get your whole team literally on the same page.
I'm that much convinced of using a wiki for QMS that I have now started my own business, helping medical device startups to build their QMS in Confluence.
Very good to see that there's a bigger community of believers!!

 

[rogerpenna]

We have tried XWiki, but it didn't work for us. Then we found Confluence, which is not open source, but very easy to use. I built our entire QMS for ISO 13485 and got it certified. Moreover as a Wiki, it became our entire knowledge-base, so our employees used it every day (auditors like that)!

The dollar-real ratio makes it prohibitive, specially because it's PER USER, and a knowledge base system must be used by all company employees.

Although not Wikis, in that case, there would be local solutions in local currency much better imho, specially because some use CONCURRENT USERS (you pay monthly for a maximum number of concurrent users, meaning you can register 300 employee users, and as long as you have no more than 15 (example) logged in at the same time, all is fine (if 15 are logged in, the 16th is just denied the login)


UNLESS Confluence has a differentiation between "Users" and "Readers".

 

[rogerpenna]

I see I'm quite late to the party, with the first post in this thread dating from 2009!
However, at my former medical device company, we performed a big quest on finding the right eQMS for ISO13485. Finally it was our IT-guy who said "what your looking for sounds a bit like Wikipedia".
In hindsight it was one of our best business decisions to use a wiki for our QMS! We settled for Confluence and it worked brilliantly for us. I built our QMS from scratch and we got it certified to ISO13485:2016. In parallel Confluence became our entire knowledge-base and it is very efficient to find information/documentation (no need to ask your colleagues where on the server to find a specific document!). The shared meeting note is also really powerful to get your whole team literally on the same page.
I'm that much convinced of using a wiki for QMS that I have now started my own business, helping medical device startups to build their QMS in Confluence.
Very good to see that there's a bigger community of believers!!

How do your company, with Confluence, handle ISO "documented information" requisites, like copy control, approvals, etc, etc?

 

[eboelen]

The dollar-real ratio makes it prohibitive, specially because it's PER USER, and a knowledge base system must be used by all company employees.

Although not Wikis, in that case, there would be local solutions in local currency much better imho, specially because some use CONCURRENT USERS (you pay monthly for a maximum number of concurrent users, meaning you can register 300 employee users, and as long as you have no more than 15 (example) logged in at the same time, all is fine (if 15 are logged in, the 16th is just denied the login)


UNLESS Confluence has a differentiation between "Users" and "Readers".

It's free up to 10 users, so ideal for startups. Unless you want permissions (which you don't need initially, but at some point you do), you have to upgrade to the paid version. Indeed you pay per user and you want all employees to be users, but also that is affordable imho, especially if you compare it to the pricing model of dedicated eQMS platforms. Plus it eliminates the use of paper notebooks for meeting notes
Still, the greatest value comes from being your central knowledge-base, so your team saves a lot of time searching for internal information.