Regulatory-ready live-cell platform for GMP environments

Laboratory products

Regulatory-ready live-cell platform for GMP environments

01 Dec, 2025

Agilent has upgraded its xCELLigence RTCA eSight system with new software that meets 21 CFR Part 11 compliance, opening the door for its use beyond research labs into GMP-regulated manufacturing and quality control.

The enhanced platform now supports secure user authentication, electronic signatures, and full audit trails, ensuring that data generated in live-cell experiments is both trustworthy and regulatory-ready. This allows researchers and manufacturers to rely on a single system throughout the drug development pipeline — from early discovery to cell therapy production — reducing variability, saving time, and streamlining compliance.

“Adding Part 11 compliance to the RTCA eSight means our customers can trust their data for both scientific insight and regulatory submissions,” said Dr Knut Wintergerst, VP and GM of Agilent’s Cell and Biomolecular Analysis Division. “It strengthens Agilent’s role as a partner across discovery and GMP-regulated environments.”

By bridging research and production, the upgraded RTCA eSight provides a unified, audit-secure solution that meets the rising demand for digital lab tools in biopharma and cell therapy manufacturing.

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