Software helps meets bioterrorism criteria
A
Wonderware product story
Edited by the Engineeringtalk editorial team
Mar 22, 2004
Wonderware now offers e-compliance solutions designed to respond to the US "Public health security and bioterrorism preparedness and response act" of 2002.
Wonderware now offers e-compliance solutions designed to respond to the US "Public health security and bioterrorism preparedness and response act" of 2002.
The Wonderware Strategic Integration Group (WSIG) will implement the eCompliance Solutions.
The Bioterrorism Response Act, signed into law by George W Bush on 12th June 2002, requires the US Food and Drug Administration (FDA) to enact and enforce regulations to protect the food supply in the event of a terrorist attack.
Every food-processing company in the USA, excluding farms and restaurants, is required to follow these regulations, which ensure that food companies can account for every link in their supply chain.
"After the regulations go into effect, it is expected that food companies and manufacturers will have to maintain records for each batch of food or other product that they produce for a minimum of two years for nonperishable products and for a minimum of one year for perishable products", said Jay Jeffreys, the Programme Manager for Wonderware's eCompliance Solutions.
The Bioterrorism Response Act requires food companies to provide the FDA with ingredient source data including immediate previous source, or IPS, and immediate subsequent recipient, or ISR, for every component used in the manufacturing process.
In addition to US food-processing companies, the Bioterrorism Response Act impacts international organisations that import or export food or other biological products to the USA.
"It is possible to keep these records on paper and still meet the Act's requirements", said Yves Dufort, WSIG's General Manager and Director of Services.
"The challenge is that the companies must provide a large amount of specific, detailed information within several hours after an investigation begins.
Electronic records greatly simplify and accelerate the data-gathering process".
The Wonderware Strategic Integration Group has closely researched the requirements associated with the Bioterrorism Response Act and designs eCompliance solutions that can help manufacturers improve operational performance, traceability and downtime tracking in addition to complying with the Bioterrorism Response Act.
WSIG also advises companies on how to achieve regulatory compliance in other areas, such as FDA 21 CFR Part 11.
"Wonderware's eCompliance Solutions incorporate features that are specifically intended to address the Bioterrorism Response Act", Jeffreys said.
"Our objective is to advise customers on what the Bioterrorism Response Act demands from them, and to provide the means to quickly and cost-effectively acquire the necessary information with easy-to-use and quickly deployable software solutions".
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