US-based Agilent Technologies Inc. has 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 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.