GMP aspects of Electronic Batch Recording - Part 1: helping to meet ALCOA+ requirements

​This article is the first part of a series based on applying the ISPE GAMP GPG Data Integrity - Manufacturing RecordsElectronic Batch Record (EBR) systems collect information about the process operation as the manufacturing progresses. Regulations require Batch Record data to be managed under the ALCOA+ principles, download the content below for a summary on how EBR ensures these principles and the typical improvement over paper record controls.

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