Thoughts on Improving Data Integrity of Pharmaceutical Production Enterprises

VernacularTitle:对完善药品生产企业数据完整性的思考
Author: Gong FENG ; Yi LIANG
Keywords: Pharmaceutical production enterprise; Data integrity; Staff; Hardware; Software; Quality management system
From: China Pharmacy 2017;28(13):1732-1735
CountryChina
Language:Chinese
Abstract: OBJECTIVE:To provide reference for improving the data integrity management system of pharmaceutical produc-tion enterprises. METHODS:According to related reports in US Food and Drug Administration(FDA)and China Food and Drug Administration(CFDA),the source of data integrity problems was analyzed,its reasons were summarized and solutions were put forward. RESULTS&CONCLUSIONS:The reasons why there were data integrity problems in enterprises can be attributed to 3 as-pects(staff,hardware/software system and quality management),and the 3 aspects showed large gap with current standards. It is suggested that enterprises evaluate the existing system by adopting the gap analysis,establish a data integrity management project team,strengthen personnel training,upgrade hardware/software system to ensure its safety,stability and effectiveness;and opti-mize the quality management system by developing good ducument specification,special regulation system of data integrity. In addi-tion,the enterprise should establish quality culture,pay attention to industry and regulatory trends in real time to guarantee the data integrity effectively.