National Bureau of Standards Special Publication 500-75 Validation, Verification, and Testing of Computer Software, 1981.įederal Information Processing Standards Publication 101, Guideline For Lifecycle Validation, Verification, and Testing of Computer Software, 1983.įederal Information Processing Standards Publication 105, Guideline for Software Documentation Management, 1984.Īmerican National Standard for Information Systems, Dictionary for Information Systems, American National Standards Institute, 1991.įDA Technical Report, Software Development Activities, July 1987.įDA Guide to Inspection of Computerized Systems in Drug Processing, 1983.įDA Guideline on General Principles of Process Validation, May 1987. IEEE Standards Collection, Software Engineering, 1994 Edition, published by the Institute of Electrical and Electronic Engineers Inc. The New IEEE Standard Dictionary of Electrical and Electronics Terms, IEEE Std. The source of such definitions appears immediately following the term or phrase in parenthesis, e.g. The terms are defined, as much as possible, using available standards. Those related terms are located sequentially to assist the user in finding all defined terms in these domains, e.g., functional testing is defined under testing, functional.

Four modifications are the grouping of terms and phrases in the domains of specifications, testing, qualification, and validation. Acronyms are expanded at the beginning of each alphabetical section and defined with the full term or phrase. Acronyms are grouped at the beginning of each alphabetical section, and are followed by words, terms and phrases. The organization of this document is primarily alphabetical. It is also a resource for investigators who conduct inspections and investigations involving software and computerized systems.

It will facilitate consistency in describing the requirements of the law and regulations applicable to such products and systems. This document is intended to serve as a glossary of terminology applicable to software development and computerized systems in FDA regulated industries. The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person(s). Note: This document is reference material for investigators and other FDA personnel.

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