摘要
目的在科学检验精神的指导下,借助实验室信息学,以中国食品药品检定研究院和北京市药品检验所近几年推进药品检验信息化建设的成果为基础,结合全国药检系统其他单位的相关经验,探索兼具科学性和实用性的全国药检系统信息化建设之路。方法检验的核心是数据,信息系统应围绕数据核心设计和建设。其基本架构应包括两个模块:一是构建检验数据采集和管理系统,即通过仪器设备网络化实现检验数据自动采集,运用科学数据系统化管理对检验数据进行存储、共享、分析,从而保证检验数据的科学性、真实性和准确性。二是构建信息管理系统,遵循实验室质量管理规范,实现实验室信息传递管理自动化,实现检验报告的完整性、溯源性和可控性。结果与结论在此基本架构上建设全国检验信息系统,实现全国检验数据资源的集中和共享,将全系统的检验数据汇总为检验信息资源,通过对资源的挖掘与分析,提升检验的技术支撑能力和水平,更好地为国家食品药品安全监管提供技术服务。
Objective To explore a scientific and practical national inspection system with the aid of laboratory informatics,based on the results of drug inspection by National Institutes for Food and Drug Control of China and Beijing Institute for Drug Control in recent years,combined with relevant experience of other institutions in the national drug inspection system.Methods The information system was developed based on the test data.The framework included two modules：First,the test data collection and management system,which achieved automatic test data acquisition by networking instruments,storing,sharing and analyzing the acquired data by systematic analysis,ensured the scientific,authentic and accurate nature of data.Second,the information management system,which performed automatic information transmission and management,ensured the integrity,traceability and controllability of inspection reports.Results and Conclusion The established system can be used as the basis for the construction of a national inspection information system.It is proposed that the centralized and shared inspection data resources be summarized and analyzed as a technical support for the upgrade of national food and drug inspection supervision.
出处
《中国药事》
CAS
2014年第10期1114-1119,共6页
Chinese Pharmaceutical Affairs
关键词
科学检验
信息化建设
仪器设备网络化
数据管理系统化
实验室信息管理系统
全国检验数据库
scientific inspection
informatization construction
instrument equipment networked
systematic data management
laboratory information management system
the national test database
