Rockwell Automation recently began offering regulatory compliance services (RCS), a resource for life sciences original equipment manufacturers seeking to minimize project risk, accelerate system development and gain a competitive advantage. The service addresses 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. It’s designed to help life sciences customers reduce engineering costs, optimize manufacturing processes and decrease time-to-market.

“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 customer’s complete system life cycle,” says Gerhard Werling, Rockwell Automation manager of regulatory compliance services. “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.”

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