Instructions for operating and maintaining the GenomeLab GeXP Genetic Analysis System, along with instructions for data acquisition, data analysis, and 21 CFR 11 tools.
Describes the software validation for the software components of the BioPhase 8800 system and lists the computer configuration and the software development environment.
Describes new enhancements and fixes to the 32 Karat software, firmware and the PA 800 Plus software and provides a summary of the software validation report. A summary of how the software supports the FDA regulation 21 CFR part 11 and summaries of previous releases of the software and firmware are also included.