“”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.