It is essential part of SAP for Pharmaceuticals, Chemicals and food processing industries where guidelines of GMP are compulsory as mandated by the U.S. Food and Drug Administration (FDA) and other international institutions have become an international standard in many areas of process industries.
With regard to product liability, the batch record contains all planned and actual data for the production process (entire production life cycle) of a batch electronically called as Electronic Batch Recording (EBR). The structure, contents, and processing of batch records comply with GMP.
EBR is recorded via PI sheet. “Electronically” indicates that batch recording is paperless. A batch record contains all quality relevant data on the production of a batch.
These batch records are approved by digital signatures. We can say it is compiled record of all business transactions like inspection lot, process order, PI sheet etc.
Important configuration settings regarding digital signatures and batch recording are available in process management and process data documentation in implementation guide in Production Planning for Process Industries section.
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By Sreedhar Babu. (on behalf of SAP Consulting Team)
Apprisia
SAP :: Streamlined
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