[技术帖] FDA在有关数据完整性的警告信中明确了CAPA的方向[
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FDA Warning Letter calls explicitly for CAPA
FDA警告信明确要求CAPA
Again, the U.S. Food and Drug Administration FDA has issued a
Warning Letter
mainly focussing on Da
ta Integrity.
又一次，美国FDA签发了主要关注数据完整性的警告信。
This new Warning Letter contains GMP observations in four areas:
新的警告信包括的缺陷在四个领域：
Incomplete da
ta in laboratory records;
化验室数据不完整
Inappropriate controls over computer systems;
计算机系统控制不恰当
Inadequate written proce