Difference between revisions of "21 CFR Part 11"

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The Title 21 Code of Federal Regulations (21 CFR Part 11) provides compliance information regarding [[Electronic records|electronic records]] and [[Electronic signatures|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 [http://www.fda.gov/ U.S Food and Drug Administration Web site] and search for 21 CFR Part 11.
The '''Title 21 Code of Federal Regulations Part 11''' ('''21 CFR Part 11''') provides compliance information regarding [[Electronic records|electronic records]] and [[Electronic signatures|electronic signatures]]. Within this part, requirements are created to help insure security, integrity, and confidentially of electronic records and to insure that electronic signatures are as legally binding as hand-written signatures.<ref>{{cite web |url=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 |title=Electronic Code of Federal Regulations - Title 21: Food and Drugs - Part 11: Electronic Records; Electronic Signatures |publisher=U.S. Government Printing Office |accessdate=02 March 2012}}</ref>
 
==Further reading==
 
* [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 Title 21 CFR Part 11]
 
==References==
<references />


[[Category:Regulatory information]]
[[Category:Regulatory information]]

Revision as of 23:29, 2 March 2012

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 insure 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

  1. ↑ "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. 
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