Wonderware Solution Aims To Help Meet FDA Regulations

Jan. 13, 2005
Technology firm Wonderware says its eCompliance Solution package will help food companies meet the final regulation of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The final regulation implements Section 306 of the ...

Technology firm Wonderware says its eCompliance Solution package will help food companies meet the final regulation of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The final regulation implements Section 306 of the Bioterrorism Act, which requires that those who manufacture, process, pack, transport, distribute, receive, hold or import food establish and maintain records. The records identify the immediate previous source of all food received as well as the immediate subsequent recipient of all the food. The final rule was issued Dec. 6, 2004, by the U.S. Food and Drug Administration. "We've been following the FDA for months as they wrestled with literally hundreds of comments and concerns expressed by food companies that will be affected," says Jay Jeffreys, program manager for Wonderware eCompliance Solutions. "During that process, Wonderware monitored the process closely to ensure that the Wonderware eCompliance Solution package will enable users to comply with the full requirements of the final version of the regulations issue by the FDA." All businesses covered by the final rule must comply within 12 months of Dec. 9, 2004, except for small and very small businesses. Small businesses (11-499 full-time equivalent employees (FTEs)) must comply within 18 months of Dec. 9, 2004, and very small businesses (10 or fewer FTEs) have to comply within 24 months, or by Dec. 9, 2006. Wonderware is a business unit of Invensys Systems Inc. It is based in Lake Forest, Calif.

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