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Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
For example, 42 C.F.R. § 260.11(a)(1) would indicate "title 42, part 260, section 11, paragraph (a)(1)." Conversationally, it would be read as "forty-two C F R two-sixty point eleven a one" or similar. While new regulations are continually becoming effective, the printed volumes of the CFR are issued once each calendar year, on this schedule:
Similarly, The Rules Governing Medicinal Products in the European Union, Volume 4, Annex 11: Computerised Systems applies to all forms of computerized systems used as part of a GMP regulated activities and defines Computer System Validation Elements [2]
Part IV: Agency Program Requirements – By far the largest section of the Supplement, this section is similar to Part III with the exception that it provides the information program by program in substantial detail. Whereas Part III simply discusses the 14 compliance requirements, this section discusses how each requirement applies to a ...
Process Safety Management of Highly Hazardous Chemicals is a regulation promulgated by the U.S. Occupational Safety and Health Administration (OSHA). [1] It defines and regulates a process safety management (PSM) program for plants using, storing, manufacturing, handling or carrying out on-site movement of hazardous materials above defined amount thresholds.
Title 21 CFR Part 11; ... Title 49 CFR Part 600 - 699; Treasury regulations This page was last edited on 29 December 2013, at 13:40 (UTC) ...
Title 14 CFR – Aeronautics and Space is one of the fifty titles that make up the United States Code of Federal Regulations (CFR). Title 14 is the principal set of rules and regulations (sometimes called administrative law) issued by the Department of Transportation and Federal Aviation Administration, federal agencies of the United States which oversee Aeronautics and Space.