Invensys introduces FDA 21CFR part 11 compliance program for I/A Series system | Automation.com

Invensys introduces FDA 21CFR part 11 compliance program for I/A Series system

New program, introduced at Interphex 2002, combines tools and services to make it easier for Foxboro’s pharmaceutical industry customers to comply with US FDA regulations for electronic records and signatures

NEW YORK, NY (INTERPHEX 2002 EXPO) – April 17, 2002 – Invensys Production Management has introduced a comprehensive program of automated tools and expert services designed to help pharmaceutical companies that use the I/A Series® automation system to comply with US Food and Drug Administration (FDA) regulations for electronic records and signatures (21CFR part 11). These tools and services can be utilized with both new and existing I/A Series systems, eliminating the need to purchase, engineer, install, and validate an entirely new system to be able to comply with 21 CFR part 11.

“While the Foxboro automation system was already at the head of the pack in terms of FDA compliance, we utilized input from our customers in the global pharmaceutical industry to fill in the few –but critical – gaps that previously existed,” said Janice Abel, a senior pharmaceutical industry consultant at Invensys Production Management. “As one example, we’ve enhanced our Foxboro Change Tracking Software to map much closer to specific electronic records and signatures requirements and thus reduce the effort required for our customers to achieve compliance.”

The Invensys program includes automated tools for change tracking, record keeping, reporting, access security, recipe management and execution, and production tracking. Services include training (both Web-based and on-site); validation services; on-site installation, configuration, and startup supervision; plus complete project management services.

“By making the validation services an integral part of our program, we have effectively addressed both the technological and procedural aspects of the 21 CFR part 11 regulations, which are equally important for compliance,” said Richard Fecteau, general manager of Invensys Pharmaceutical Solutions. “To the best of our knowledge, Invensys is the only automation vendor that can provide customers with both appropriate technology and well-proven validation expertise on a global basis.”

For more information, call Richard Fecteau (514/485-8043), Janice Abel (508/549-6373), or visit http://www.foxboro.com/iaseries/automation_systems/hottopics/21_cfr.htm.

This is just one of several programs in place at Invensys specifically designed to address the unique requirements of the company’s global pharmaceutical industry customers. For example, Wonderware, Foxboro’s sister unit in the Production Management division, recently launched a major new initiative to lower the cost of implementing and maintaining 21CFR part 11 validated applications utilizing its InBatch, InTouch, and InSQL products.

Invensys plc, the international production technology and energy management group, specializes in helping companies to improve efficiency, performance and profitability. With close to 76,000 employees, Invensys is headquartered in London, England.

Our Production Management businesses work closely with customers in order to drive up performance of their production assets and maximize the return on investments in product technologies. The division includes APV, Avantis, Baan, Eurotherm, Foxboro, Pacific Simulation, Simulation Sciences, Triconex, and Wonderware and it addresses the oil, gas, and chemicals; food, beverage, pharmaceutical and personal healthcare; power; pulp and paper; and discrete and hybrid manufacturing sectors.

Our Energy Management businesses actively work with clients involved in both the supply and consumption of energy, developing systems using innovative technologies that improve the reliability and security of power supplies. The division includes Energy Solutions, Metering Systems, Appliance and Climate Controls and Power Systems and focuses on markets connected with power and energy infrastructure and commercial and residential buildings.

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