Agilent Technologies Inc. has unveiled a significant enhancement to its cell analysis portfolio with the introduction of a newly developed 21 CFR Part 11 compliance software package for the Agilent xCELLigence Real-Time Cell Analysis (RTCA) eSight system. This advancement marks an important milestone for laboratories and biopharmaceutical organizations that increasingly rely on digital tools capable of meeting stringent regulatory requirements. With the release of this compliance-driven software—complete with a dedicated license and upgraded security architecture—Agilent is enabling its multiplex live-cell analysis platform to serve not only in drug discovery and development settings but also in GMP-regulated manufacturing and quality control environments. The expanded applicability of the eSight platform supports a more streamlined and continuous workflow spanning early research, process development, and commercial production.
For years, the xCELLigence RTCA eSight system has been valued for its integrated live-cell imaging and impedance-based real-time cell analysis capabilities, which allow researchers to capture dynamic cellular responses with high sensitivity and temporal resolution. However, the increasing demands of regulated biopharma manufacturing—particularly in fields such as biologics, advanced cell therapies, viral vector production, and precision medicine—have created a pressing need for instrumentation that can meet specialized compliance standards. Agilent’s new software version is designed specifically to address these evolving expectations by bringing the system firmly in line with FDA 21 CFR Part 11, the regulatory framework that governs electronic records and electronic signatures in the context of pharmaceutical and biomanufacturing quality systems.
At the core of the upgrade are several meticulously developed Part 11-aligned capabilities, including secure user authentication, configurable password policies, and multi-level permissions that ensure only authorized personnel can access, modify, or approve data. The software also incorporates electronic signatures linked to specific user actions, along with full audit trails that capture a complete, immutable history of system usage, data acquisition, analysis workflows, and any attempted changes. These controls collectively help guarantee that all recorded data are attributable, legible, contemporaneous, original, and accurate—the principles known as ALCOA, which define global data integrity standards.
By embedding these features directly into the RTCA eSight ecosystem, Agilent is enabling laboratories to avoid the patchwork approach of relying on external compliance tools or manual procedures to maintain regulatory alignment. Instead, users can operate the system with the confidence that its data architecture, analytical outputs, and security framework already conform to the requirements expected by auditors, compliance officers, and regulators worldwide. This allows both research-focused and production-focused teams to work within the same technological environment, reducing handoff discrepancies and helping organizations maintain consistency across the entire drug development lifecycle.
One of the most meaningful implications of this upgrade is the system’s new suitability for GMP (Good Manufacturing Practice) environments, where validation, process monitoring, and lot release workflows demand uncompromising reliability and traceability. For manufacturers of biologics and cell-based therapies, the need to maintain transparent, audit-ready digital records has become increasingly important as regulatory agencies intensify their scrutiny of data management practices. The enhanced RTCA eSight platform provides a direct response to these requirements by ensuring that every recorded measurement—from early kinetic cell profiles to final manufacturing QC tests—is securely captured and compliant.
Customers implementing the system in GMP settings are expected to benefit from improved audit readiness, reduced risk of data loss or alteration, and a smoother path when preparing regulatory submissions for clinical trials, new drug applications, or post-market manufacturing changes. Agilent’s stronger integration of compliance features also simplifies internal recordkeeping and digital documentation, helping laboratories avoid duplication, transcription errors, or fragmented data storage practices. Overall, these improvements result in measurable gains in operational efficiency and regulatory confidence.
Importantly, the new compliance package does not impose any limitations on the system’s analytical speed, performance, or ease of use. Instead, it maintains the fluidity and flexibility that research laboratories have long valued in the RTCA eSight platform. Scientists can continue to leverage real-time cellular impedance measurements combined with high-content imaging to evaluate cell health, proliferation, cytotoxicity, morphology, and functional changes with unparalleled detail. The regulatory enhancements simply add a robust layer of security and traceability, making the system versatile enough to support everything from exploratory cell biology to final manufacturing workflows.
According to Dr. Knut Wintergerst, vice president and general manager of Agilent’s Cell and Biomolecular Analysis Division, the release reflects Agilent’s commitment to strengthening its offerings across the entire biopharma development chain. “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,” Dr. Wintergerst stated. “This strengthens Agilent’s role as a trusted provider in both discovery and GMP-regulated environments, including manufacturing and quality control.”
The upgraded software also aligns with the broader industry trend toward integrating regulated and non-regulated workflows within unified digital ecosystems. As organizations strive to accelerate the pace of innovation while meeting increasingly complex quality expectations, the ability to deploy consistent platforms across all phases of development becomes a strategic advantage. Continuous data continuity—from research assays to manufacturing analytics—can significantly reduce variability, simplify method transfer, and improve reproducibility.
Moreover, the adoption of regulatory-ready instrumentation is particularly crucial for the rapidly expanding field of cell therapy, where the complexity of living products requires highly controlled and well-documented production processes. Real-time cell analysis platforms like the RTCA eSight play an essential role in monitoring cell behavior, optimizing production parameters, and confirming product quality. Agilent’s compliance enhancements therefore position the system as a valuable asset for companies developing CAR-T therapies, stem cell-based treatments, regenerative medicine solutions, and emerging personalized therapeutics.
Taken together, the release of Agilent’s 21 CFR Part 11 compliance software for the xCELLigence RTCA eSight system underscores the company’s broader strategy of delivering reliable, secure, and audit-ready scientific solutions to support the development of next-generation medicines. By combining regulatory robustness with the system’s advanced live-cell analysis capabilities, Agilent is equipping researchers, developers, and manufacturers with a platform that supports innovation while meeting the highest data integrity standards required in today’s biopharmaceutical landscape.
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