Ionetics 1/29/96 electrolyte analyzers 1. Failure to ensure specification changes are subject to controls as stringent as those applied to the original specifications of the device [21 CFR 820.100(a)(2)]. For example, your firm failed to document and approve changes made to components and software for your electrolyte analyzers.Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.