ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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User

(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

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

User

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

User

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

User

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

Publication Date:

See also: Owner/User

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