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Data Integrity

FDA statistics, over the years (2014-2019) identified the Data Integrity (DI) events as the most cited on the Warning Letter. The year 2020 was atypical. Many colleagues considered the year as tumultuous and wearisome. Other industry colleagues were more resilient and hopeful. However, the data integrity issues continue to be cited in warning letters with a reduced quantity rate due to the limited traveling from the FDA CSO officials. The steady frequency in DI citations is troubling because ensuring data integrity is an important component and pharmaceutical responsibility to ensure the SISPQ of the drug continues to be in alignment with the previously approved dossier by the agency.

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220105_Data Integrity rev 2-1
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Gil, Martinez-Betancourt
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