ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Requirement

(IEEE) A condition or capability needed by a user to solve or achieve an objective. Also, a condition or capability that must be met or possessed by a system or system component to satisfy a contract, standard, specification, or other formally imposed documents.

Publication Source: GAMP® 4: Good Automated Manufacturing Practice Guide for Validation of Automated Systems

Requirement

(ISO) Need or expectation that is stated, generally implied or obligatory.

Publication Source: GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems

Publication Date: 2008

Requirement

A documented representation of a condition or capability.

Publication Source: FDA Glossary of Computerized System and Software Development Technology

See also: Design Requirement Functional Requirement Implementation Requirement Interface Requirement Performance Requirement Physical Requirement

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