Date: 20 April 2010
Link: FDA Warning Letter (New Window)
ObservationThis is a follow up letter from an inspection in 2009 where the security of laboratory systems had been raised within the FDA 483.
6. Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by
Wednesday, 2 March 2011
CSV FDA Warning Letters : Laboratory Systems Security
Posted on 10:12 by Unknown
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