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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
The Electronic Signatures in Global and National Commerce Act (ESIGN, Pub. L. 106–229 (text), 114 Stat. 464, enacted June 30, 2000, 15 U.S.C. ch. 96) is a United States federal law, passed by the U.S. Congress to facilitate the use of electronic records and electronic signatures in interstate and foreign commerce.
Download as PDF; Printable version; ... Title 21 CFR Part 11; Title 47 CFR Part 15; Title 47 CFR Part 68; Title 47 CFR Part 97; Title 49 CFR Part 600 - 699;
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
Download as PDF; Printable version; In other projects ... US FDA 21 CFR Part 11 [1]) computerized system to ensure that it does exactly what it is designed to do in a ...
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:
Controlled Substances Act, a part of the Comprehensive Drug Abuse Prevention and Control Act of 1970. 21 U.S.C. ch. 14 — [Alcohol and Drug Abuse Educational Programs and Activities] (repealed) 21 U.S.C. ch. 15 — Egg Products Inspection