Electronic Batch Records and Flexible Batch Reporting

Overview:

S88.01 defines batch history as 'a collection of data relating to one batch'. This is expanded by S88.02 to show that a batch history is an aggregation of both common and batch specific elements. A batch history may be made up of data collected by several systems and held in multiple locations. From this collection of data it may be required to produce for different purposes several batch reports. This paper reviews with the aid of case studies some methods of implementing flexible batch historian and batch reporting systems and discusses some of the issues faced such as 21CFR part 11 compliance and the integration of time series data and batch event data.

Author: Eur Ing C. M. Marklew BSc CEng FinstMC MIEE, Aston Dane plc  | File Type: PDF

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