ISPE Glossary of Pharmaceutical and Biotechnology Terminology

ISPE Glossary

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(ISO) Management system to direct and control an organization with regard to quality.

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

(ISO) The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

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

Publication Date: 2005

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