Search results
Results from the WOW.Com Content Network
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
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.
21 U.S.C. ch. 7 — Practice of Pharmacy and Sale of Poisons in Consular Districts in China; 21 U.S.C. ch. 8 — Narcotic Farms (repealed) 21 U.S.C. ch. 9 — Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ch. 10 — Poultry and Poultry Products Inspection Poultry Products Inspection Act of 1957; 21 U.S.C. ch. 11 — Manufacture of Narcotic ...
Toggle the table of contents. Computerized system validation. ... US FDA 21 CFR Part 11 [1]) computerized system to ensure that it does exactly what it is designed to ...
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:
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) ...
Specifically, instead of having a separate body of regulations for a PMA Fabrication Inspection System (FIS), [18] as was the case in prior regulations, the PMA regulations now include a cross reference to the 14 C.F.R. § 21.137, [19] which is the regulation defining the elements of a quality system for all production approval holders. [20]