FDA Warning Letter: Validations of software processes not completed (ucm458487)

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Ofni Systems

 
“”CAPA QS-13-006 identified corrective actions to your firm’s software validation procedure and identified 50 software processes that were not validated. Your firm closed the CAPA as effective on April 15, 2015; however, the validations for 38 of the identified software processes were not completed [Kurihara-shi, Miyagi].

The adequacy of your firm’s responses cannot be determined at this time. Your firm initiated a CAPA to address the above deficiencies. However, your firm has not completed implementation of its corrective actions and CAPA effectiveness verifications for this observation.”

View the original warning letter.


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