Company: Sooil Development Co. Ltd.Product:Insulin infusion pump Date: 11/24/04 Failure to document the results of the design validation in the design history file, as required by 21 CFR 820.30(g). For example, the documentation of the bolus and basal infusion testing involving the dispensing software was incomplete. Additionally, as part of your software validation, the report...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.