ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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(ANSI) Any person, organization, or functional unit that uses the services of an information processing system.

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

See also: End User


The person, or persons, who operate or interact directly with the system. The User(s) and the Customer(s) are often not the same person(s), but may be.

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

See also: Customer


The pharmaceutical customer or user organization contracting a supplier to provide a product. In the context of GAMP 5 it is, therefore, not intended to apply only to individuals who use the system, and is synonymous with customer.

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

Publication Date: 2008


The person or persons who operate or interact directly with the system.

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

Publication Date: 2012


Publication Source: American Society of Mechanical Engineers (ASME), Bioprocessing Equipment (BPE) - 2009 Revision

Publication Date:

See also: Owner/User

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