Analysis and enlightenment of the main problems of data integrality in FDA warning letters
YANG Zhu-ren
ZHAO Shuang-chun
ZHAO Hong-ju
Abstract：Studying data management guidelines issued by developed countries and organizations,and analyzing data integrity in the warning letters issued by US FDA,and to provide references for improving data management in drug manufacturing enterprises.Mainly data integrity deficiencies displays in concealed,discarded,amend or even fabricated data.Drug manufacturing enterprises should pay more attention to credit system construction,standardize the habitual behavior and improve the data management ability in order to suit the needs of industrial development.
Keywords：data integrityFDAwarning letters
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2759-2763 )