Abstract: Objective To study data integrity defects of drug manufacturers, in order to provide reference for regulators and pharmaceutical industry. Methods By analyzing the domestic and foreign data management laws and guides, and classifying the common data integrity defects in drug manufacturers, the study makes statistical analysis on the data integrity defects which were found in CFDA GMP unannounced inspection, GMP follow-up inspection and observation of international inspection in 2016. Results The basic requirements of data management are defined. Main data integrity defects which existing in drug manufacturers and causes are identified. Conclusion The paper provides suggestions on improving data management and references to enhance the data management ability in the pharmaceutical industry.

Key words: data integrity, drug production, computerized system