Thanks! That is how I read it as well just thought I would get additional
input.

Stephanie

-----Original Message-----
From: Records Management Program [mailto:[log in to unmask]] On Behalf
Of Larry Medina
Sent: Thursday, June 16, 2011 11:50 AM
To: [log in to unmask]
Subject: Re: 21 CFR Part 11

Stephanie-

These parts of your post:

"The agency believes that, in general, the kinds of operator actions that
need to be covered by an audit trail are those important enough to
memorialize in the electronic record itself."

"Subsequent ‘‘saved’’ corrections made after such a commitment, however,
must be part of the audit trail."

"Accordingly, the agency has revised proposed § 11.10(e) by removing
reference to all write-to-file operations and clarifying that the audit
trail is to cover operator entries and actions that create, modify, or
delete electronic records."

Lead me to believe that yes, those metadata changes/actions would need to be
recorded.  Naturally, it depends in part on what the elements of metadata
are that are being captured, but some changes could result in a
category/record series change, a corresponding retention change, or other
aspects that impact how the record is located in a search.

Hope this helps-

Larry
[log in to unmask]
 (btw, tell Kevin I said Hi!)

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