21 CFR Part 11
From LIMSWiki
Revision as of 14:03, 13 April 2011 by Jleecbd (talk | contribs) (moved CFR Part 11 to 21 CFR Part 11: The 21 unambiguously references the correct title of the code. Presumably there are part 11's to other titles.)
The Title 21 Code of Federal Regulations (21 CFR Part 11) provides compliance information regarding Electronic Records and Electronic Signatures. Basically, certain guidelines 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 http://www.fda.gov/ and search for CFR Part 11.