Title 21 CFR Part 11

Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). 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)).

Coverage

Practically speaking, Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions. It requires that they implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data that FDA predicate rules require them to maintain. 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.

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CIO

CIO may refer to:

Organizations

Central Imagery Office, a predecessor of the American National Geospatial-Intelligence Agency

Central Intelligence Office, the national intelligence agency of the former Republic of Vietnam

Central Intelligence Organisation, the national intelligence agency of Zimbabwe

Charitable incorporated organisation, a form of legal entity for non-profits in the United Kingdom

Congress of Industrial Organizations, a former American trade union federation (also known as the Committee of Industrial Organization)

International Olympic Committee (French: Comité international olympique)

Titles

Chairman-in-Office, is an official of a member state holding the presidency of an international organization

Chief information officer, the head of information technology

Chief innovation officer, the head of innovation, responsible for innovation management

Chief investment officer, the head of investments

Commonwealth Chairperson-in-Office, the Chairperson-in-Office of the Commonwealth of Nations

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CIO magazine

CIO was founded in 1987 in Framingham, Massachusetts, to serve executives and technology decision makers in the information technology field and the burgeoning role of Chief Information Officer. The publication, created as part of Boston-based International Data Group's enterprise publications business, was built to deliver CIO-focused news, features and commentary on emerging technologies and products, industry trends and research, innovation in the tech industry, and legal and regulatory implications of technology.

The CIO portfolio currently includes CIO Magazine and CIO.com, as well as CIO Executive Programs, CIO Strategic Marketing Services, CIO Forum on LinkedIn, CIO Executive Council and CIO primary research. Serving CIOs and other IT leaders, CIO.com, CIO magazine, CIO Executive Programs, CIO Custom Solutions Group and the CIO Executive Council are produced by IDG Enterprise, a business unit of IDG.

CIO Magazine

The monthly magazine was started in 1987, when the CIO title was new and relatively unknown in corporate America. Today, CIOs direct IT strategy and direction as well as more tactical technology operations at Fortune 1000 companies. They have to be fluent in technology and business issues, and they work closely with other company leaders in various business functions. The magazine has a qualified circulation of 140,000 readers, most of whom are CIOs and senior IT leaders.

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