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 organization 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.