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Analysis Of CY2018 FDA Warning Letters That Cite Data Integrity Failures

An evaluation of warning letters associated with data governance and data integrity deficiencies. In this summary, we identify: • CY2018 warning letters that cite data integrity deficiencies • The number of warning letters citing this topic in the past 11 years and the countries where these sites are located • The regulations identified most frequently in CY2018 drug GMP [...]

By |2019-07-30T18:19:56+00:00May 22nd, 2019|Special Reports|