- published: 07 Mar 2016
- views: 43918
Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
Practically speaking, Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions, to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are (a) required to be maintained by the FDA predicate rules or (b) used to demonstrate compliance to a predicate rule. A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. [1]
Thomas Leo "Tom" Clancy, Jr. (born April 12, 1947) is an American author, best known for his technically detailed espionage, military science, and techno thriller storylines set during and in the aftermath of the Cold War, along with video games on which he did not work, but which bear his name for licensing and promotional purposes. His name is also a brand for similar movie scripts written by ghost writers and many series of non-fiction books on military subjects and merged biographies of key leaders. He is Vice Chairman of Community Activities and Public Affairs, as well as a part-owner, of the MLB Baltimore Orioles.
Clancy was born in Baltimore, Maryland. He attended Loyola Blakefield in Towson, Maryland, graduating with the class of 1965. He then attended Loyola College in Baltimore, graduating in 1969. Before making his literary debut, he spent some time running an independent insurance agency. This agency thrived for a few years before joining a group of investors.
Clancy and his first wife Wanda married in 1969, separated briefly in 1995, and permanently separated in December 1996. Clancy filed for divorce in November 1997, which became final in January 1999.