Regulatory compliance services assist life sciences OEMs
New OEM-specific regulatory compliance services (RCS) from Rockwell Automation are intended to help life sciences original equipment manufacturers minimize project risks and accelerate system development.
New OEM-specific regulatory compliance services (RCS) from Rockwell Automation are intended to help life sciences original equipment manufacturers minimize project risks and accelerate system development. 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 managements, and GMP training.
The RCS team is said to work closely with OEMs to assess project risks, review application requirements, establish protocols and procedures, and assist with regulatory standards implementation. OEMs receive customer-tailored training programs for ongoing compliance assurance, vendor audit preparation and program management, and guidance on maintaining computer system compliance and validation. Services are available as part of an automation or information project or as a stand-alone service.
“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.
—Jeanine Katzel, senior editor, Control Engineering, firstname.lastname@example.org