SmartBatch™ Electronic Batch Record System
SmartBatch Electronic Batch Record System helps pharmaceutical companies meet the critical challenges of increasing productivity while maintaining compliance levels required by the FDA in the new “Risk based approach to the GMPs for the 21st century.” SmartBatch is a procedure execution and electronic batch record solution. It’s a standard product alternative to complex, highly customized MES systems.
 SmartBatch frees operators, supervisors, managers and quality assurance analysts from devoting large amounts of time consumed by manual activities that are done to ensure that batch records are filled in completely and correctly. By automating these labor intensive activities, savings of 50% or more are realized, primarily in areas of data capture, document preparation, and QA review.
Operators use SmartBatch as they use paper batch records. A procedure is opened electronically (on a hand-held PC), data is captured electronically and within the context of the process procedure, and then the operator signs. Another operator can sign in to continue that procedure, while the original operator moves on to another record. Managers can assign, review, and approve operators’ work. Trending reports and batch certificates can be automatically generated for review. Data can be exported to other corporate systems such as LIMS, MES, or ERP.
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