ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Electronic Batch Record (EBR)

Electronic records in one or more systems/applications comprised of the elements of paper Master Batch Records as well as production batch records. These elements typically include Work Instructions and recipes equivalent to Master Batch Records, as well as actual results, e-signatures, and data from execution equivalent to paper production batch records.

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

Publication Date: 2010

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