ObservationDate: 25 April 11
Link FDA Warning Letter (New Window)
4. 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 authorized personnel [21 C.F.R 211.68(b)].
For example, your firm lacks control of the (b)(4) computer system which monitors equipment,
Wednesday, 18 May 2011
FDA Warning Letter - Secure Desktop
Posted on 10:35 by Unknown
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