LAKE FOREST, Calif., July 30, 2002 -- Invensys plc today announced a comprehensive program to help pharmaceutical companies using Wonderware products comply with 21 CFR Part 11 U.S. Food and Drug Administration (FDA) regulations for electronic records and signatures.
This new initiative unites the expertise of Validation Technologies -- a part of the Invensys Pharmaceutical Solutions group that specializes in computer systems validation and regulatory compliance in FDA-regulated industries -- with Wonderware, a business unit of Invensys. Together they plan to offer solutions enabling pharmaceutical customers to achieve regulatory compliance more quickly and with greater cost effectiveness.
Validation Technologies is working as an auditor and consultant for Wonderware and is contributing its broad knowledge of specific FDA requirements that the pharmaceutical industry must follow. The combination of Validation Technologies' FDA-compliance expertise and Wonderware's extensive background in the industrial control software field will facilitate the business unit's customer efforts to more easily comply with 21 CFR Part 11 and other regulatory requirements.
"By making Validation Technologies services an integral part of this initiative, we can effectively address 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. "Invensys is one of the few automation vendors that can provide customers with both the appropriate technology and proven global validation experience."
The Validation Technologies and Wonderware alliance is one example of Invensys' recent efforts to help companies using Wonderware products lower the costs of qualification, re-qualification and development of pharmaceutical applications.
Validation Technologies has actively consulted with Wonderware on 21 CFR Part 11 requirements to help the business unit establish software development standards that meet and exceed regulatory requirements. The collaboration of these two industry leaders will result in continued Wonderware product enhancements, which will enhance customer FDA-compliance strategies.
"Validation Technologies input on product development issues relating to FDA requirements enables Wonderware to significantly extend product functionality, allowing users to more easily develop FDA-compliant applications," said Tim Sowell, Wonderware's vice president of product management.
"Validation Technologies has just completed a detailed study on Wonderware's product roadmap and provided direct input into plans for the next versions of Wonderware's products through 2004. This relationship significantly increases the business unit's expertise in FDA requirements, influencing the direction of new products."
About Wonderware
Wonderware is an operating unit of the Production Management Division (PMD) of Invensys plc and is the world's leading supplier of industrial automation software. Founded in 1987, the company pioneered the use of Microsoft® Windows®-based, human machine-interface (HMI) automation software for manufacturing operation systems. Wonderware's mission is to provide integrated software suites that drive the customer's strategic, planning and operational decision-making based on real-time plant floor information.
Based in Lake Forest, Calif., Wonderware has regional sales and development offices throughout North America, Europe, Latin America and Asia to provide support to its network of more than 160 distributor offices. Wonderware has completed more than 180,000 successful installations in more than 30,000 plants worldwide.
About Validation Technologies
Validation Technologies is part of Invensys Pharmaceutical Solutions, a group within the Production Management Division (PMD) of Invensys, and a leading supplier of validation, pharmaceutical, engineering and regulatory-compliant solutions. Founded in 1994 and with over 110 dedicated consultants, the group is currently one of the largest suppliers of regulatory-compliant solutions in North America and Europe, dedicated to the pharmaceutical, biological, biotechnology and device industry.
Validation Technologies' mission is to contribute to the success of its clients by providing them with regulatory-compliant solutions that will improve their ability to develop, manufacture and deliver pharmaceutical products to the market.
Based in Montreal, Validation Technologies has regional presence throughout North America and Europe. For more information, visit the Invensys Pharmaceutical Solutions Web site at www.vtc-usa.com.
About Invensys
Invensys plc (www.invensys.com) is an international production technology and energy management company specializing in helping companies to improve efficiency, performance and profitability. Headquartered in London, Invensys has about 45,000 employees worldwide.
Invensys' Production Management Division works closely with customers to enhance production asset performance and maximize return on investment (ROI) in product technologies. The division business units include APV, Avantis, Baan, Esscor, Eurotherm, Foxboro, PacSim, SIMSCI, Triconex and Wonderware. The division addresses the production needs of the oil, gas and chemicals industries; food, beverage and personal healthcare markets; and the discrete and hybrid manufacturing sectors.
The Invensys Energy Management Division (EMD) business units work actively with clients involved in both the supply and consumption of energy and water resources. They develop innovative systems and technologies that improve the management of energy and water efficiency and the reliability and security of power supplies. The division includes Energy Solutions, Metering Systems, Home, Appliance and Climate Controls and Powerware business units. Together, they focus on markets connected with power and energy infrastructure and commercial and residential buildings.
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Invensys, Wonderware and Validation Technologies are trademarks of Invensys plc, its subsidiaries and affiliated companies. All other brands are trademarks of their respective owners.
