New compliance software from Wonderware to assist food companies in meeting FDA reporting requirements
Lake Forest, CA — December 17, 2004 — Wonderware, a business unit of Invensys Systems Inc., today announced that its Wonderware eCompliance Solution package is designed to help food companies meet the requirements of the reporting and record-keeping rule announced by the U.S. Food and Drug Administration on December 9, 2004.
The regulation requires companies to establish, maintain and, upon request, provide access to records as directed by the U.S. Congress in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
The new regulation requires food companies to provide the FDA with ingredient source data, including immediate previous source (IPS) and immediate subsequent recipient (ISR) for every component used in the manufacturing process. In addition to U.S. food processing, transportation and distribution companies, the regulation impacts international organizations that import or export food or other biological products to the United States.
"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," said Jay Jeffreys, program manager for Wonderware eCompliance Solutions. "The FDA has had to work hard to deliver rules that will allow it to deal with a national emergency involving our food supply, without putting an unbearable strain on the food companies themselves. In some areas the FDA made compromises from its original proposed rule, in some cases they stood firm. 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 issued by the FDA."
In addition to requiring IPS and ISR information, the regulations call for food companies to keep records needed to determine exactly which ingredient lots go into shipments of food released to the marketplace. Food processing companies will be required to keep these records for a minimum of six months for foods with a shelf life of 60 days or less and up to two years for foods with a shelf life of more than six months. Large firms with more than 500 employees are required to comply by December 9, 2005, while small firms with 10 or fewer employees have up to 24 months to comply, by December 9, 2006.
"Many companies expressed serious concerns about their ability to deliver so much detailed information in a short time when an investigation takes place," said Jim Brown, strategic sales manager for Wonderware eCompliance Solutions. "Wonderware's solution not only makes that important task simple, but is still affordable, secure and paperless, regardless of the companies' existing business and/or operations systems."
The FDA regulations for establishment, maintenance and availability of records under 21CFR, Part 1, Subpart J affect more than 200,000 manufacturing, wholesale and packaging sites in the United States. Electronic records simplify and accelerate the data-gathering process, and Wonderware eCompliance Solutions provide manufacturers tools to improve operational performance, traceability and downtime tracking in addition to complying with the new reporting regulations.