FDA Title 21 CFR Part 11
Title 21 CFR Part 11 of the Code of Federal Regulations is an Food and Drug Administration (FDA) regulation for drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries that defines the criteria under which electronic records and electronic signatures are considered to be equivalent to paper records.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=11