I like to know how I can obtain a document which details the FDA requirements for controls and machinery design.

 

This is a long subject. You'll be looking for CFR 21 Part 11 compliance. GAMP is a good place to start, available at http://www.ispe.org . Expect to pay a couple hundred bucks for the documents, but in the end it's worth it.

Larry

 

See http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=199821