Computer Validation

In August 2001, Food and Drug Administration (FDA) of the United States published a draft Guidance For Industry titled - 21 CFR Part 11: Electronic Records; Electronic Signatures - Glossary of Terms asking for comments from industry. This document gives a new FDA definition for computer validation as shown below.

Computer Systems Validation:

Confirmation by examination and provision of objective evidence that computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled.

See the glossary for further Computerized System and Software Development Terminology