21 CFR Part 11
http://www.fda.gov/ora/compliance_ref/part11/
http://www.adneurope.com/fr/21CFRPART11/21_CFR_PART_11/21CFRPART11.htm
http://www.21cfrpart11.com/
http://www.21cfrpart11.com/pages/faq/index.htm