Merck Millipore Guava easyCyte™ Systems for Compliance with 21 CFR Part 11

This white paper provides a summary of how the easyCyte™ system addresses the regulatory requirements outlined by 21 CFR Part 11. 21 CFR Part 11 is the United States Food and Drug Administration (U.S. FDA) regulation, directing the management of electronic records and electronic signatures in open and closed systems. The regulation became effective in March 1997 and Merck Millipore’s guava® instruments featuring CytoSoft™ and guavaSoft™ software were designed to facilitate user compliance with 21 CFR Part 11.