Agilent Announces Enhanced xCELLigence RTCA Software Pro to Support Regulatory Compliance Requirements

6 June 2023 -- California, US -- Agilent Technologies today announced the release of the enhanced xCELLigence RTCA Software Pro Version 2.8, an integrated software package for running and analysing real-time cell analysis data. This improved version enables Agilent xCELLigence Real-Time Cell Analysis (RTCA) systems in GMP-regulated facilities.

The xCELLigence RTCA Software Pro enables data integrity controls to support regulatory requirements defined in FDA 21 CFR Part 11 and EU GMP Annex 11 for electronic records and electronic signatures, an essential requirement in pharmaceutical and biopharmaceutical manufacturing. New and enhanced features ensure that data and electronic records generated with xCELLigence RTCA systems are trustworthy, authentic and reliable and meet GMP manufacturing compliance requirements.

The xCELLigence RTCA system provides an essential functional potency assay in cell therapy development, manufacturing and safety applications. Agilent instrumentation and software, alongside customer user organisation controls, enables customers to meet FDA 21 CFR Part 11 and other applicable regulatory requirements. This system empowers customers to meet the demands of cell therapy discovery, process development, and QC-release criteria.

“The addition of compliance features to xCELLigence RTCA Software Pro ensures that Agilent xCELLigence RTCA systems meet the regulatory needs of our valued customers, especially in manufacturing and quality control settings,” said Todd Christian, vice president and general manager of Agilent’s Cell Analysis Division. “This bridges the regulatory gap, and reinforces Agilent as a leading cell analysis solutions provider to the pharma and biopharma industries.”

Agilent’s key focus is to support customers’ regulatory requirements through our instrumentation and software applications. These solutions for compliant environments support immuno-oncology and cell and gene therapy customers, who are developing key components to address human health concerns, furthering Agilent’s core mission to advance the quality of human life.

About Agilent Technologies
Agilent Technologies is a global leader in the life sciences, diagnostics and applied chemical markets, 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 $6.85bn in fiscal 2022 and employs 18,000 people worldwide. Information about Agilent is available at www.agilent.com.