Consultant with Office 365 experience

#1
Hi,

We are looking for a skilled consultant who can help us with setting up our Office 365 to be compliant with ISO13485 and FDA part 11 compliant.

Can you point me in the direction of anyone who would have done this before?

/Emil
 
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yodon

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#2
What exactly do you mean? Are you trying to set up, maybe, a SharePoint site to implement document and records controls? Otherwise, I'm not sure what the intersection is.
 
#3
a specification would be
1) set up a document management system with appropriate tags
2) make an approval flow and add azure tags to be part 11 compliant
3) structure document templates to add version tags and approval status
4) assist in software validation.
5) potentially assist in implementing lists/other tools for eg audit trails, suppliers and risk management.
 
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