21 CFR Part 11

The Title 21 Code of Federal Regulations (21 CFR Part 11) provides compliance information regarding Electronic Records and Electronic Signatures. Within this part, requirements are set forth to help insure security, integrity, and confidentially of electronic records and to insure that electronic signatures are as legally binding as hand-written signatures. For more information, refer to the U.S Food and Drug Administration Web site and search for 21 CFR Part 11.