FDA21 CFR stands for “Title 21 of the Code of Federal Regulations” concerning control measures and regulations regarding food and drug safety falling under the jurisdiction of the United States Food and Drug Administration (FDA).
“Part 11” which became effective in August, 1997 outlines regulations concerning the FDA requirements for accepting electronic records in lieu of paper records and defines the procedures and controls for ensuring the authenticity, integrity, non-repudiation and confidentiality of electronic records and signatures. A copy of the rule is available at http://www.fda.gov/ora/compliance_ref/part11 |
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