Recipient: Stratec Medizintechnik Gmbh Product: bone densitometer. Date: 9/10/2008 Failure to adequately document acceptance activities, as required by 21 CFR 820.80(e). For example: The printouts contained in the DHR derived from computer software used to calibrate and test the finished device do not include the name of individual or contain the signature of the individual...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 email@example.com for more info.