Date: 16 April 2007
Link: FDA Warning Letter (New Window)
Observation
6. Appropriate controls are not exercised over computers or related systems to assure that changes in analytical methods or other control records are instituted only by authorized personnel [21 CFR 211.68(b)]. Specifically,
a) There was a failure to validate the [redacted] software to assure that all data generated by the
Wednesday, 2 June 2010
CSV FDA Warning Letters : Security
Posted on 11:34 by Unknown
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