OpenLAB系统软件在色谱检测中的应用  

Application of OpenLAB System Software in the Chromatographic Detection

作　　者：刘爱琴 马金萍[2] 蔡淑慧 晁红娟[2] 王有芳[2] 杨艳梅[2] 于建[2] 许新德[2] LIU Ai-qin;MA Jin-ping;CAI Shu-hui;CHAO Hong-juan;WANG You-fang;YANG Yan-mei;YU Jian;XU Xin-de(Zhejiang Keming Biopharmaceuticals Co.,Ltd.,Xinchang 312500,China;Zhejiang Medicine Co.,Ltd.Xinchang Pharma Factory,Xinchang 312500,China)

机构地区：[1]浙江可明生物医药有限公司,浙江新昌312500 [2]浙江医药股份有限公司新昌制药厂,浙江新昌312500

出　　处：《化工管理》2022年第34期56-58,共3页Chemical Engineering Management

摘　　要：随着医药行业监管的日益成熟,GMP法规执行更加标准化,对药品生产经营企业,数据完整性在药品质量监管中变得越来越重要,OpenLAB系统软件在气相色谱和液相色谱中的应用,确保了检测数据的完整性,保障了产品的可追溯性,为药品的注册、监管及质量控制等带来保障。文章主要介绍了OpenLAB系统软件的安全策略、角色和权限、数据管理和系统维护,为OpenLAB系统软件在色谱检测中的应用及数据完整性提供参考。With the increasing maturity of pharmaceutical regulation and standardization of GMP regulations,data integrity is becoming more and more important in drug quality supervision for drug manufacturers and dealers.The application of OpenLAB system software in the gas chromatography and liquid chromatography ensures the integrity of test data and the traceability of products.It will guarantee the registration,supervision and quality control of drugs.This paper mainly introduces the security policy,role and authority,data management and system maintenance of OpenLAB system,providing reference for the application and data integrity of OpenLAB system software in chromatographic detection.

关 键 词：OpenLAB 系统软件 检测 数据完整性 

分 类 号：TQ46[化学工程—制药化工]