FDA Technical Reference on Software Development

FDA Office of Regulatory Affair’s “TECHNICAL REFERENCE ON SOFTWARE DEVELOPMENT” issued July 1, 1987 as guidance to inspectors regarding software. This guidance is dated but still sometimes referenced in other publications. It provides some textbook type information as educational material for use in inspections but is no longer heavily utilized.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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