Merck Millipore Guava easyCyte™ Systems for Compliance with 21 CFR Part 11
Merck Millipore Guava easyCyte™ Systems for Compliance with 21 CFR Part 11
31 Dec 2015This 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.
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Guava® easyCyte™
LuminexOur microcapillary flow cytometry systems are simpler to operate than traditional sheath-fluid based instruments and are far easier to maintain. They utilize small sample volumes, generate minimal waste, and have lower operating costs. As a result, easyCyte™ Flow Cytometers are uniquely amenable to on-demand use in the laboratory environment and have helped many scientists achieve insightful cellular analysis since 1998.