Controls over Systems Documentation in 21 CFR Part 11

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pseudoazurin

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#1
#1
Hi All,

I am looking at 21 CFR Part 11.10 (k), which asks for controls over systems documentation: including: (1) distribution of, access to, and use of documentation for system operation and maintenance, (2) revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.

Those look like universal requirements, why is it so special that needs to be highlighted in 21CFR11? What is FDA especially looking for in those requirements with respect to 21CFR11?

Anyone?
 
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Enternationalist

Enternationalist

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#2
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What do you mean? 21 CFR 11 is meant to be a place defining very general electronic records and signatures requirements. Where else would these go? They need to ask us to have that information somewhere.
 
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