Recipient: Mavidon Medical Products Product:Class II Mavidon Medical Electrode Jelly. Date: 8/8/2008 7. Failure to validate, according to an established protocol, computer software for its intended use, when that software is used as part of the Quality System or part of production as required by 21 CFR 820.70(i). The regulation under 21 CFR 820.70(i) requires...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.