Kalypso, a Rockwell Automation (NYSE: ROK) business, today announced its inclusion as a Representative Vendor in the 2024 Gartner® Market Guide for Life Science Regulatory Information Management (RIM) Solutions. Kalypso was recognized for its Digital Regulatory Information Management solution tailored for the medical device industry.

Gartner notes that “Regulatory information management vendors continue to innovate and consolidate solutions into integrated platforms for greater optimization and automation.” The report further highlights that Life science CIOs want to reduce the complexity of their regulatory IT systems and accompanying traditional business processes to speed regulatory submissions and lower costs.

Kalypso’s RIM solution is designed to help life sciences companies bring compliant products to global markets faster, while meeting country-specific regulatory requirements. The platform enables organizations to manage and track product registrations, improve submission accuracy, manage global UDI data, and support efficient product distribution—all within a unified, integrated system.

“We believe our recognition in Gartner’s Market Guide validates our commitment to delivering a cost-effective, scalable accelerator for RIM system implementation,” said Rod Walters, Lead Principal, Life Sciences at Kalypso. “Our solution consolidates compliance and quality data from across the enterprise into a single source of truth, enabling faster, more accurate regulatory submissions and global market access.”

As life sciences companies face increasing pressure to scale internationally, the need for a globally unified approach to product registration, submission, and market tracking has never been more critical. ‘’Vendors that focus on end-to-end regulatory information management (RIM) address these challenges by reducing unnecessary preproduction work, quality checks and complex system integrations via middleware solutions.’’

“Non-compliance is not an option—it’s costly, damaging to brand reputation, and potentially harmful to patients,” Walters added.

For more information about Kalypso’s Digital RIM solutions, visit www.kalypso.com.

⁽¹⁾ Gartner, Inc. "Market Guide for Life Science Regulatory Information Management Solutions" by Jeff Smith, September 2, 2024

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About Rockwell Automation

Rockwell Automation, Inc. (NYSE: ROK) is a global leader in industrial automation and digital transformation. We connect the imaginations of people with the potential of technology to expand what is humanly possible, making the world more productive and more sustainable. Headquartered in Milwaukee, Wisconsin, Rockwell Automation employs approximately 27,000 problem solvers dedicated to our customers in more than 100 countries as of fiscal year end 2024. To learn more about how we are bringing the Connected Enterprise® to life across industrial enterprises, visit www.rockwellautomation.com.

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