Nikkiso Co. Ltd. 1/27/98 Hemodialyzers
2. Failure to validate computer software for its intended use according to an established protocol when software is used as part of production or the quality system, as required by 21 CFR 820.75(j). For example, the software used to perform _____ has not been validated. This software is part of the quality system and controls the _____ Your management indicated to the investigator that its personnel did not have the knowledge to validate or test the software and would have to be trained in the area.
