Agilent Announces 21 CFR Part 11 Compliance Software for xCELLigence RTCA eSight
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21 CFR Part 11regulatory
21 CFR Part 11 is a U.S. regulatory rule that sets requirements for how electronic records and electronic signatures must be created, stored and protected so they can be trusted as if they were paper documents. For investors, it matters because companies that handle regulated data—like clinical trial results or manufacturing logs—must meet these controls or face regulatory delays, fines or lost market access; think of it as a lock-and-audit trail for digital paperwork.
gmp-regulatedregulatory
GMP-regulated means a product or facility must follow Good Manufacturing Practice rules—detailed quality standards set by regulators to ensure drugs, medical devices, and certain health products are made safely and consistently. For investors, GMP regulation matters because compliance reduces the risk of product recalls, regulatory fines or shutdowns and supports reliable supply and market access, much like a kitchen following strict recipes and hygiene rules to prevent spoiled food and keep customers safe.
electronic signaturesregulatory
Electronic signatures are digital marks or codes that confirm a person’s agreement to a document or transaction without a handwritten signature, like typing your name, clicking “I agree,” or using a secure digital stamp. They matter to investors because they speed up deals, cut paperwork costs and reduce legal uncertainty—similar to signing a contract with a trusted app instead of mailing paper—so companies can close transactions and report results faster and with clearer audit trails.
audit trailstechnical
A record of every step, change and action taken on financial records, transactions or documents that creates a clear ‘breadcrumb trail’ from start to finish. Investors care because it lets auditors, regulators and shareholders verify that numbers are accurate, trace the cause of errors or suspicious activity, and assess whether controls are working — much like CCTV footage helps confirm what really happened in an incident.
real-time cell analysismedical
Real-time cell analysis is a laboratory method that watches living cells continuously and records how they change in response to a drug, chemical or condition, much like a live video or meter that tracks activity over time. For investors, it matters because it produces faster, more detailed evidence about a therapy’s effectiveness and safety, helping drug developers make earlier go/no-go decisions and potentially reducing the time, cost and risk in a development program.
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.
