ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Electronic Batch Record System (EBRS)

One or more systems/applications that facilitate the creation/revision, approval, distribution, execution, and data collection of Electronic Batch record elements; a computer system that stores, in electronic format, the batch record information required by healthcare regulations.

Publication Source: GAMP® Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach

Publication Date: 2010

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