Quality Management Systems - Differences between ISO 13485, 21 CFR Part 820 & ICH Q10

D

daamor

#1
I'm looking for a comparison matrix of QMS elements from ISO13485/21 CFR 820 VS. ICH Q10 (new guidance on QMS for pharma).

From a practical standpoint- I'm trying to expand my knowledge base to be able to do a QMS audit on pharma companies. Most of the work I've done is in med devices.

Does anybody know where I can get good comparison on differences between QMS elements and common deliverables (V&V, etc.) in pharma vs. med dev?
 
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Stijloor

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#2
Re: Quality Management Systems - Differences between ISO 13485, 21 CFR Part 820 & ICH

A Quick Bump!

Can someone help?

Thank you very much!!
 

sagai

Quite Involved in Discussions
#3
Re: Quality Management Systems - Differences between ISO 13485, 21 CFR Part 820 & ICH

I think it could be subject for a year long PhD study.
I do not think it is a 'let's have a checklist and go' question.
Cheers!
 
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