>Anyone have any experience dealing with, and care to comment on, FDA requirements for electronic records to be considered equivalent to paper records?
>
>http://www.fda.gov/ora/compliance_ref/part11/frs/background/11cfr-fr.htm
>
>TIA.

Yes, is the short answer.
Drop Janice Birnie a line at qa@file-away.co.uk (tell her I sent you!)

http://www.file-away.co.uk/qa.htm
http://www.file-away.co.uk/itaudits.htm
http://www.file-away.co.uk/erecords.htm (for links)

You could also look at www.sqa.org, www.barqa.com - the former US-based and the latter international (even though it is called British). You could also join the BARQA mailing list (email to computing@barqachat.com subject SUBSCRIBE) and ask questions there.

The FDA has recently (slightly) relaxed some of the rules for 21CFR. Basically it is audit trails, record retention (electronic, etc.) and, mixed up with it, electronic authorisation of records.