Agilent Enhances xCELLigence RTCA Software Pro for Regulatory Compliance

Agilent Technologies has launched an enhanced version of its xCELLigence RTCA Software Pro, version 2.8, an integrated software package for running and analyzing real-time cell analysis data. This updated version enables Agilent xCELLigence Real-Time Cell Analysis (RTCA) systems to operate in GMP-regulated facilities.

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

The xCELLigence RTCA system serves as a critical functional potency assay for cell therapy development, manufacturing, and safety applications. Agilent's instrumentation and software, coupled with customer user organization controls, assist clients in meeting FDA 21 CFR Part 11 and other applicable regulatory demands. The system empowers customers in cell therapy research, process development, and quality control 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, particularly 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 focuses on supporting customer regulatory requirements through its instrumentation and software applications. These compliant environment solutions support customers in immuno-oncology and cell and gene therapy who are developing key components to address human health concerns, furthering Agilent's mission to advance the quality of human life.