Agilent Launches 21 CFR Part 11 Software for RTCA eSight

Agilent Technologies Inc. has launched new 21 CFR Part 11 compliant software for its xCELLigence Real-Time Cell Analysis (RTCA) eSight system.

This upgrade introduces a compliance license along with advanced security features, enabling the multiplex live-cell analysis platform to be utilized not only in drug discovery and research labs but also in GMP-regulated manufacturing and quality control environments.

The enhancement supports seamless workflow across the pharma and biopharma value chain, from early-stage research to production.

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The software addresses growing demand for regulatory-ready digital lab solutions in biopharma and cell therapy manufacturing, where data integrity and audit readiness are essential. Key features include secure user authentication, electronic signatures, and complete audit trails, ensuring all generated data is reliable, traceable, and fully compliant.By extending the xCELLigence RTCA eSight to regulated environments, Agilent allows users to maintain high-quality data without affecting efficiency, simplifying audits, regulatory submissions, and consistency across the drug development process.

“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.”