实验室信息管理系统(LIMS)在药检领域的应用

摘要

In order to meet various business requirements of Dalian Institute for Drug Control,this essay is going to design a Laboratory Information Management System(LIMS) based on instruction of Good Automated Manufacturing Practice(GAMP5).By analyzing and designing system module,Dalian Institute for Drug Control is able to conduct risk management in the fields of process management,static data management,profile administration,and administrative control of measuring instrument.It increases the security and liability of data and process in experiments.The application of Laboratory Information Management System(LIMS) also enables Dalian Institute for Drug Control to enhance its work effectiveness by raising its degree of standardization and automation.%根据本所的业务需求,结合GAMP5(良好自动化生产实践指南)验证规范要求.建立符合自身需求的LIMS模块,对流程管理,静态数据管理,文件管理,检验管理,计量器具管理等进行风险控制.从而保障流程和数据的安全性,可靠性.建立规范的LIMS使用制度,提高了检验的标准化和自动化程度,提高了工作效率.