From: sverli [sverli@c2i.net]
Sent: Monday, December 02, 2002 2:22 PM
To: fdadockets@oc.fda.gov
Subject: Submission for Docket 00D-1539

Sirs,

The first sentence in chapter 2.1 confuses me; "Part 11 applies to electronic records and electronic signatures that persons create, modify, maintain ...". The way I interpret the sentence trigger some questions and thoughts.

What about records created by production equipment, instruments etc. where persons only initiate the creation of records? (Pushing a start button is a typical scenario.) Records are then automatically created during processing.

I do not think the intention is to exclude such records by interpret the regulation in this way, so a different wording on the subject is preferred from my point of view.



Regards
Lindgaard Engineering

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  Mr. S-E. Lindgaard