Drager Medizintechnik GmbH, 6-Aug-99, Intensive care ventilators, anesthesia and incubators
1. Failure to validate computer software used as part of the quality system for its intended use according to an established protocol as required by 21 CFR 820.70(i). For example, the data in the Excel spreadsheet identified as a “Hit List” of top nonconforming components contains 16 record counts for Part number 8601618 DC converter failures compared to 18 record counts for Part number 860168 DC converter failures in the dbase database. The spreadsheet is used for management review of component suppliers for all components.
