中国药业2025，Vol.34Issue(22)：7-11,5.DOI:10.3969/j.issn.1006-4931.2025.22.002
贵州省药品生产企业计算机化系统及电子数据管理相关缺陷分析与对策研究
Analysis on Defects and Countermeasures Related to Computerized Systems and Electronic Data Management in Pharmaceutical Manufacturing Enterprises of Guizhou Province
摘要
Abstract
Objective To analyze the defects related to computerized systems and electronic data management in pharmaceutical manufacturing enterprises,and to study countermeasures.Methods Based on domestic and foreign regulatory requirements and industry status,defects in computerized systems and electronic data management found in Good Manufacturing Practice(GMP)inspections of pharmaceutical manufacturing enterprises by domestic and foreign regulatory authorities in recent years were reviewed,and their characteristics and risks were summarized.Systematic improvement suggestions were put forward according to typical problems found in on-site GMP inspections in Guizhou Province.Results The informatization level of pharmaceutical manufacturing enterprises in Guizhou Province showed a polarized status.The main defects included insufficient validation and verification of computerized systems,incomplete data,unclear responsibilities for access control and privilege management,absence of change control procedures,weak supplier management,absence of audit trail functions,unscientific data backup management,incompatible system interfaces,and untimely system updates.It is suggested to establish a verification strategy covering the entire life cycle of the system,clarify data integrity requirements,implement the ″one person,one account″ and ″least privilege principle″ in account management,incorporate all changes to computerized systems into the quality management system,sign quality agreements with suppliers to clarify compliance responsibilities,regularly test data backup and recovery procedures,conduct special verification on data transmission interfaces among different systems,and perform gap analysis on old systems.Conclusion Pharmaceutical manufacturing enterprises should build a ″compliance-intelligence-safety″ trinity management system,and continuously improve the compliance level of computerized system application in accordance with industry laws and regulations,national policy trends and the current status of informatization promotion.关键词
药品生产企业/计算机化系统/电子数据管理/《药品生产质量管理规范》Key words
pharmaceutical manufacturing enterprise/computerized system/electronic data management/Good Manufacturing Practice分类
医药卫生引用本文复制引用
郭祺瑞,徐剑,张永萍..贵州省药品生产企业计算机化系统及电子数据管理相关缺陷分析与对策研究[J].中国药业,2025,34(22):7-11,5.基金项目
贵州省高层次创新型人才项目[黔科合平台人才-GCC[2023]037] （）
贵州省科技计划项目[黔科合中引地[2023]006]. （）
