Date: 07 May 2009
Link: FDA Warning Letter (New Window)
Observation5. Your firm has not exercised appropriate controls over computer or related systems to assure that changes in control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)J. For example, one user account is established for two analysts to access the laboratory instrument's software on the
Thursday, 20 May 2010
CSV FDA Warning Letters : Security
Posted on 10:26 by Unknown
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