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home > pmps > winter 2001 > the american food and drug administration and electronic records
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Pharmaceutical Manufacturing and Packing Sourcer

The American Food and Drug Administration and Electronic Records

Chart recorders have progressed considerably over the past few years. No longer is the humble chart recorder just a paper record of a process. For a long time now there have been many additional options such as maths channels, chart annotation, logic-based events and so on. The user now has considerably more options with paperless graphic recorders capable of offering all types of communication and displays. Recorders can now reside on a network and data can be transferred, viewed and managed remotely. The chart recorder world continues to move towards a complete data management solution.

In many batch processes the operator or supervisor records the batch information by writing onto the paper chart, signing and dating it, and attaching the paper record to the batch information. This method is simple but there is only one copy of the information. If the chart is damaged in any way, a whole batch of product may be forfeited - a very costly penalty. A graphical recorder gives the user more flexibility and more archive options. Information is stored in an electronic format and can be retrieved and archived in several ways. If the paper print-out is lost or damaged, the operator can simply print another identical copy from the secure data archive. This does, however, raise certain issues on how to prevent records being tampered with.


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By Karen Rigby, Business Product Manager for Eurotherm Limited Karen Rigby is the Business Product Manager for Eurotherm Limited. Karen's responsibilities include the marketing strategy and product definition of Eurotherm's data management business, including the traditional Chessell chart recorders. Karen gained an honours degree in Electronic and Electrical Engineering from the University of Birmingham. She subsequently joined Daniel Europe Ltd - part of the Emerson Group. Karen left her position of UK Sales Manager at Daniel to join Eurotherm in October 2000.
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Karen Rigby
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