ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Software

Any executable program which operates on an automated system.

Publication Source: ISPE Baseline® Guide, Vol. 1: Active Pharmaceutical Ingredients, Second Edition

Publication Date: 2007

Software

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Publication Source: ISPE Baseline® Guide, Vol. 1: Active Pharmaceutical Ingredients, Second Edition

Publication Date: 2007

Software

(ANSI) Programs, procedures, rules, and any associated documentation pertaining to the operation of a system.

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

See also: Application Software Operating System System Software Utility Software

Contrast with:

Software

(IEEE) Computer programs, procedures, and associated documentation and data pertaining to the operation of a computer system.

Publication Source: GAMP® Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition)

Publication Date: 2012

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