Date: 21 May 2010
Link: FDA Warning Letter (New Window)
Observation6. Your firm failed to check the accuracy of the input to and output from the computer or related systems of formulas or other records or data and establish the degree and frequency of input/output verifications [21 CFR § 211.68(b)].
For example, the performance qualification of your (b)(4) system software (Validation No.
Tuesday, 15 June 2010
CSV FDA Warning Letter : Periodic Review
Posted on 03:58 by Unknown
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