Agilent Announces 21 CFR Part 11 Compliance Software for xCELLigence RTCA eSight

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12/01/2025 - 08:00 AM

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc (NYSE: A) today announced the release of a new 21 CFR Part 11 compliance software for the Agilent xCELLigence Real-Time Cell Analysis (RTCA) eSight system. The software includes a compliance license and enhanced security features, allowing this multiplex live-cell analysis system to be deployed not only in drug discovery and development labs but now also in GMP-regulated manufacturing and quality control settings. Extending the platform’s use across the pharma and biopharma value chain will help support continuity from early-stage drug discovery and research to production.

The new software is designed to address a rising demand for regulatory-ready digital lab tools in biopharma and cell therapy manufacturing, where data integrity and audit-readiness are critical. Built-in Part 11 compliance and security features have been added to the xCELLigence RTCA eSight, including secure user authentication, electronic signatures, and complete audit trails, assuring users that the data they generate is trustworthy, attributable, and compliant.

With this upgrade, the RTCA eSight offers robust support for regulated environments without compromising on workflow efficiency or data quality. Customers working in GMP environments gain assurance that their electronic records and audit trails meet regulatory standards, helping to streamline audits and support successful regulatory submissions. Extending the same platform used in research to manufacture also helps reduce variability, save time, and simplify compliance across the drug development pipeline.

“Adding 21 CFR Part 11 compliance to the Agilent xCELLigence RTCA eSight ensures that customers can rely on their data not just for breakthrough scientific discoveries and insights, but also for regulatory compliance,” said Dr. Knut Wintergerst, vice president and general manager of the Cell and Biomolecular Analysis Division at Agilent. “This strengthens Agilent’s role as a trusted provider in both discovery and GMP-regulated environments, including manufacturing and quality control.”

Expanding the use of RTCA eSight into regulated markets underscores Agilent’s commitment to delivering reliable, compliance-ready, and audit-secure solutions to support customers at every stage in the development of next-generation cell therapies.

About Agilent Technologies

Agilent Technologies, Inc. (NYSE: A) is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.95 billion in fiscal year 2025 and employs approximately 18,000 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn and Facebook.