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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
This is widely used in the Pharmaceutical, Life Sciences and BioTech industries and is a cousin of Software Testing but with a more formal and documented approach. The validation process begins with validation planning, system requirements definition, testing and verification activities, and validation reporting.
Treasury Regulations are the tax regulations issued by the United States Internal Revenue Service (IRS), a bureau of the United States Department of the Treasury.These regulations are the Treasury Department's official interpretations of the Internal Revenue Code [1] and are one source of U.S. federal income tax law.
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) ...
The term "income" is not defined in the Internal Revenue Code. The closest that Congress comes to defining income is found in the definition of "gross income" in Internal Revenue Code section 61, which is largely unchanged from its predecessor, the original Section 22(a) definition of income in the Revenue Act of 1913: Sec. 22(a).
More commonly, this is reported on the income statement as "income (or loss) before taxes". Taxes are then subtracted from the pre-tax income to give a final net income or net profit (or net loss) figure. Net income or net profit which is not expended to shareholders in the form of dividends becomes part of retained earnings.