![]() 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. ![]()
0 Comments
Leave a Reply. |
Details
AuthorWrite something about yourself. No need to be fancy, just an overview. Archives
February 2023
Categories |