21 CFR Part 11
From LIMSWiki
The Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) provides compliance information regarding electronic records and electronic signatures. Within this part, requirements are created to help ensure security, integrity, and confidentially of electronic records and to insure that electronic signatures are as legally binding as hand-written signatures.[1]
Further reading
References
- ↑ "Electronic Code of Federal Regulations - Title 21: Food and Drugs - Part 11: Electronic Records; Electronic Signatures". U.S. Government Printing Office. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=5ff3a0efed913ef8fae9e225869688a2&rgn=div5&view=text&node=21:1.0.1.1.7&idno=21. Retrieved 02 March 2012.