Quality Electrodynamics, LLC..Product: cois used in conjunction with MRI scanners . Date: 4/10/2015 Failure to document validation activities, as required by 21 CFR 820.75(a). Specifically, The setting (temperature and line speed) used during the validation studies for the reflow oven, which is part of the SMT (Surface Mount Technology) line, to determine the optimum settings...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.