MILWAUKEE, April 26, 2005 — Life sciences original equipment manufacturers (OEMs) seeking to minimize project risk, accelerate system development and gain a competitive edge may now tap new OEM-specific Regulatory Compliance Services (RCS) from Rockwell Automation. “Life sciences OEMs must have the knowledge, resources and application expertise to meet their customers’ unique application and regulatory requirements, including the ability to provide the tools, plans and procedures to improve the efficiency and reliability of the customers’ complete system life cycle,” said Gerhard Werling, manager of regulatory compliance services, Rockwell Automation. “With our RCS team, we can help OEMs enhance their market value by helping optimize processes, maximize resources and focus priorities on the organization’s business drivers and product goals.” By utilizing Rockwell Automation’s long-established familiarity with regulatory issues, OEMs can help their life sciences customers reduce engineering costs, optimize manufacturing processes and decrease time-to-market. The services address a broad range of compliance issues, including system design consulting, computer system validation, protocol execution, qualification planning, risk assessments and audits, quality system consulting, 21 CFR Part 11 compliance, process analytical technology, electronic records management and GMP training.The Rockwell Automation RCS team works closely with OEMs to assess project risks, review application requirements, establish protocols and procedures, and assist with regulatory standards implementation. OEMs also receive customer-tailored training programs for ongoing compliance assurance, vendor audit preparation and program management, and guidance on maintaining computer system compliance and validation. Applying proven methodologies, international standards and Current Good Manufacturing Practices (cGMPs), the RCS help OEMs simplify documentation, reduce project risk, identify quality enhancements and proactively assist with end-user regulatory compliance. Rockwell Automation customers seeking RCS may obtain these services as part of an automation or information project or as a stand-alone service. For more information, visit www.rockwellautomation.com/thecompleteoem.Rockwell Automation (NYSE: ROK) is a leading global provider of automation, power, control, and information solutions that help manufacturers achieve a competitive advantage in their businesses. Headquartered in Milwaukee, Wis., U.S.A., the company employs about 20,000 people serving customers in more than 80 countries. For more information on the Regulatory Compliance Services (RCS) from Rockwell Automation, please contact the Rockwell Automation Response Center, 10701 Hampshire Avenue South, Bloomington, Minn., 55438, 800.223.5354, Ext. 1793.
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