FDA 21 CFR Part 11

Υποβλήθηκε από Bertrand Ricque την Κυρ, 2008/09/07 - 15:15.
Όνομα: 
Title 21 Code of Federal Regulations - Electronic Records; Electronic Signatures
S&P Type: 
Methodology
Referent type: 
NFP organization
Referent: 
FDA

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the FDA guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.

Web links: 
FDA
21 CFR part 11
Wikipedia