BioPhase 8800 System 21 CFR Part 11 Compliance Features

By Richard Carson, Marcia Santos, Sahana Mollah SCIEX, Brea, CA

This document is limited to sections of 21 CFR Part 11 where the customer can use the design and features of the BioPhase 8800 system to facilitate compliance with 21 CFR Part 11. Review the details of this system along with data collection system, software, and controls that should be considered with each institution's policies and procedures to achieve compliance with 21 CFR Part 11.