ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Subject Matter Expert (SME)

A person who possesses a documented deep comprehension of the theory and concepts within his or her field of work.

Publication Source: GAMP® Good Practice Guide: IT Infrastructure Control and Compliance

Publication Date: 2005

Subject Matter Expert (SME)

Those individuals with specific expertise in a particular area or field. Subject Matter experts should take the lead role in the verification of computerized systems. Subject Matter expert responsibilities include planning and defining verification strategies, defining acceptance criteria, selection of appropriate test methods, execution of verification tests, and reviewing results.

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

Publication Date: 2008

Subject Matter expert (SME)

An individual possessing in-depth knowledge of the particular subject based upon their education, training, and experience.

Publication Source: ISPE Good Practice Guide: Maintenance

Publication Date: 2009

Subject Matter Expert (SME)

Those individuals with specific expertise in a particular area or field. SME responsibilities include planning and defining verification strategies, defining acceptance criteria, selection of appropriate test methods, execution of verification tests, and reviewing results. (ASTM E2500-07)

Publication Source: ISPE Good Practice Guide: Process Gases

Publication Date: 2011

Subject Matter Expert (SME)

Those individuals with specific expertise in a particular area or field. Subject Matter experts should take the lead role in the verification of computerized systems.

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

Publication Date: 2011

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