21 CFR part 11 version differences

Seekingknowledgee

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#1
Hi all,

I am trying to find the differences between the 21 CFR part 11 1997 version and the 2003 version.
I see the 2003 version is just a guidance of how to follow the 1997 version? Correct me if I’m wrong.

Also, Are there any changes/modification/contradictions to any points in the 1997 version that the 2003 version mentions?

I’m unable to find the changes online if there are any.

Thank you
 
Last edited:
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yodon

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#2
I don't think there have been any changes to the content of the regulation. As it's part of the Code of Federal Regulations (my emphasis) then it's still law (i.e., cannot be a guidance).

According to this website (no involvement), in 2003 was when they did a reset on the enforcement policy ("enforcement discretion"), withdrew the original guidance docs, and published a new guidance doc.
 
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