Agilent Launches Compliance Software for xCELLigence RTCA eSight to Meet 21 CFR Part 11 Standards
Agilent Technologies Inc., a global leader in analytical instrumentation, diagnostics, and scientific innovation, has announced the launch of a new 21 CFR Part 11 compliance software package designed specifically for the Agilent xCELLigence Real-Time Cell Analysis (RTCA) eSight system. This significant enhancement marks an important milestone for the platform, enabling its use not only in research and drug discovery workflows but also in highly regulated environments, including Good Manufacturing Practice (GMP)–controlled manufacturing, quality control laboratories, and clinical production facilities.
The new software release includes a dedicated compliance license and an expanded suite of security and data governance features. By strengthening data integrity protections and aligning with regulatory expectations, the updated software ensures the xCELLigence RTCA eSight system can fully support customers across the pharmaceutical and biopharmaceutical value chain. The upgrade helps bridge the gap between early-stage exploratory research and late-stage production environments, ultimately supporting continuity, efficiency, and quality throughout the drug development lifecycle.
Meeting the Growing Demand for Regulatory-Ready Digital Lab Platforms
Over the past decade, the biomedical and biomanufacturing sectors have seen rapid growth in digital workflows, automated instrumentation, and data-driven decision-making. This transition has brought increased attention to regulatory frameworks governing electronic data, especially FDA 21 CFR Part 11, which outlines requirements for electronic signatures, auditability, traceability, and secure data handling.
With the accelerating adoption of cell therapies, biologics, vaccines, and live-cell analytical platforms, there is rising demand for tools that are not only scientifically powerful but also compliant with modern regulatory expectations. Agilent’s new compliance-ready software for the RTCA eSight directly addresses this industry shift by embedding audit-readiness into the workflow itself, eliminating the need for external validation tools or manual oversight.
Built-In Compliance Features to Strengthen Data Integrity
With this release, Agilent has introduced multiple new features that support data governance and regulatory reporting, including:
- Secure user authentication and role-based access control
- Electronic signature support for method execution, results approval, and record locking
- Comprehensive, uneditable audit trails capturing all user activity and data changes
- Encrypted file structure and data export controls
- Centralized system activity reporting
Together, these enhancements help ensure that data generated on the RTCA eSight platform is attributable, legible, contemporaneous, original, and accurate—fully aligning with ALCOA+ data integrity principles. Regulatory teams and QA/QC leaders can now rely on system-generated records as compliant documentation suitable for regulatory submissions and manufacturing batch records.
Enabling Seamless Transition From Discovery to Commercialization
Historically, many cell analysis systems have been used solely in research settings, requiring teams to transfer assays and validation data onto separate compliance-enabled platforms for manufacturing or clinical use. Such transitions are often resource-intensive, introduce variability, and extend timelines.
By incorporating 21 CFR Part 11 compliance directly into the xCELLigence RTCA eSight environment, Agilent eliminates these barriers. Researchers can now work on the same platform during discovery, assay development, scale-up, and clinical manufacturing, ensuring:
- Lower variability and improved reproducibility
- More efficient technology transfer
- Reduced data loss and workflow disruption
- Shorter time to regulatory review and approval
This continuity offers clear advantages for companies pursuing accelerated therapy development, including manufacturers of advanced biologics, antibody therapies, and cell-based therapeutics.
Leadership Perspective and Strategic Impact
“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 Agilent’s Cell and Biomolecular Analysis Division. “This strengthens Agilent’s role as a trusted provider in both research and GMP-regulated environments, including manufacturing and quality control.”
Dr. Wintergerst emphasized that this launch is part of a broader strategy to expand Agilent’s footprint in the fast-growing cell therapy and biomanufacturing sectors. As these industries push toward automated and standardized workflows, compliance-ready instrumentation is increasingly essential for operational success.
Supporting Next-Generation Cell Therapy and Bioprocessing Platforms
The xCELLigence RTCA eSight system is widely recognized for its ability to perform multiplex real-time live-cell monitoring, combining label-free impedance-based cell analysis with high-content imaging. These capabilities make it especially valuable for applications such as:
- Cell therapy potency assessment
- Immuno-oncology mechanistic studies
- Monoclonal antibody characterization
- Viral vaccine development
- Batch release testing and stability monitoring
By enhancing regulatory readiness while maintaining advanced scientific capabilities, Agilent is positioning the RTCA eSight system as a versatile tool capable of supporting the entire product lifecycle—from ideation to clinical deployment.
A Step Forward in Compliance, Innovation, and Customer Enablement
Agilent’s expansion of the RTCA eSight platform into regulated environments demonstrates the company’s continued commitment to aligning its technologies with the evolving needs of the biopharmaceutical industry. This upgrade supports researchers, developers, and manufacturing teams with a streamlined pathway from early experimentation to large-scale production, without compromising scientific integrity or regulatory expectations.
As biopharma organizations push toward automation, traceability, and digital manufacturing, Agilent’s compliance-focused innovation ensures customers are equipped with the tools needed to operate confidently in increasingly regulated and data-driven settings.
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