Posts in Notified Bodies

Document Control Software Systems

November 30th, 2015 Posted by Document control, Notified Bodies 0 thoughts on “Document Control Software Systems”

Do I need a full validation of QPack, or is Orcanos COC is enough?

November 11th, 2014 Posted by 21 CFR Part 11, 510(k), CE Marking, Notified Bodies, Pre Market Approval (PMA), QPack Validation 0 thoughts on “Do I need a full validation of QPack, or is Orcanos COC is enough?”

What is COC: Type Approval or Certificate of Conformity is granted to a product that meets a minimum set of regulatory, technical and safety requirements.

Orcanos provides this certification for its customers, but the question whether its instead of QPack validation, well, in some places it is enough, for example in Europe (CE), and in some places its not, such as in US, FDA, where the medical device manufacturer must do a full validation of any IT software he uses, based on the intended use.

You need to check with your regulatory consultant about it.

Orcanos

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