Rockwell Automation has released a new industry insights report examining how life sciences manufacturers are using digital technologies to move from periodic regulatory preparation towards continuous operational readiness. Titled The New Operating Model for Life Sciences Manufacturing: Moving from Compliance to Continuous Readiness, the report draws on responses from manufacturing and industrial operations decision-makers across the life sciences sector. It examines the role of connected data, cybersecurity and artificial intelligence (AI) in improving operational visibility, quality processes and readiness for changing regulatory requirements.
According to Rockwell Automation’s State of Smart Manufacturing research, 90% of life sciences manufacturers consider digital transformation necessary, while 58% have deployed smart manufacturing technologies at scale or across parts of their operations. The report finds that technology investments are increasingly being linked to specific business outcomes. AI and machine learning were identified by 46% of respondents as technologies expected to deliver the biggest business outcomes, followed by process automation at 44% and cybersecurity at 39%. Manufacturers said their investments are primarily aimed at improving quality, cited by 43%, digitising operations at 36% and reducing risk at 35%.
AI adoption is also increasing, although data readiness remains a challenge. Among manufacturers already using AI, 64% plan to expand its use over the next year, while 49% expect to increase AI investment over the next five years. At the same time, only 32% of respondents said they effectively use more than half of the data they collect.
“Manufacturers used to treat regulatory readiness as a project — something they ramped up for,” said Matt Weaver, vice president, global industry – life sciences, Rockwell Automation. “Now, it has to be a daily discipline built into how the facility runs. The companies connecting their data, securing systems and validating AI deployments today are the ones that will be ready for what comes next from regulators or from the market.”
The report also identifies cybersecurity as a lifecycle requirement. Fifty-four per cent of life sciences organisations reported experiencing at least one cyberattack during the past year. The highest areas of exposure were IT systems and enterprise networks at 41%, remote access and connected equipment at 33%, and IT/OT integration points at 29%.
The report outlines seven actions manufacturers can take to establish continuous readiness, including evidence management, cyber resilience, industrial data operations, defined AI use cases and AI governance. The findings are based on responses from 104 managers and executives representing life sciences manufacturers, OEMs, system integrators and engineering, procurement and construction companies across 16 countries. The research forms part of Rockwell Automation’s 11th annual State of Smart Manufacturing report.
Rockwell Automation, Inc (NYSE: ROK) is a global provider of industrial automation and digital transformation solutions. Headquartered in Milwaukee, Wisconsin, the company employs approximately 26,000 people and serves customers in more than 100 countries as of fiscal year-end 2025.
