Reviewing Documents - FDA Time Requirements?

A

Axelgaarder

#1
Hello all-- we are updating to a new doc control software app, and one feature is that we can set a time frame to review a document. As in, it is revised (new rev) 11/13/07 and needs to be reviewed by 6 or 12 months from then. Does FDA and/or ISO (13485) have any requirements how often controlled doc's must be reviewed? If so, where can I find that requirement?

Thanks!
peg
:bigwave:
 
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Ajit Basrur

Staff member
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#2
Re: Reviewing Doc's--FDA Time Requirements?

Hello all-- we are updating to a new doc control software app, and one feature is that we can set a time frame to review a document. As in, it is revised (new rev) 11/13/07 and needs to be reviewed by 6 or 12 months from then. Does FDA and/or ISO (13485) have any requirements how often controlled doc's must be reviewed? If so, where can I find that requirement?

Thanks!
peg
:bigwave:
Welcome to the Cove

Are you referring to the periodic review of the documents ?

If yes, there is no guidelines for determining the frequency - it has to be decided by your organizationbased on the criticality of the documents. Typically for most procedures, I would assign yearly review but have seen some organizations adopting a 2 years review period too.

Hope that helps.
 
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