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Citation[]

Food and Drug Administration, Glossary of Computer System Software Development Terminology (Aug. 1995, as amended) (full-text).

Overview[]

This document is intended to serve as a glossary of terminology applicable to software development and computerized systems in FDA regulated industries. It will facilitate consistency in describing the requirements of the law and regulations applicable to such products and systems. It is also a resource for investigators who conduct inspections and investigations involving software and computerized systems.

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