建立计算机化系统保障CGT研发数据完整性的实践与探讨  

Practice and Discussion on Establishing Computerized System to Ensure Data Integrity of CGT R&D

作　　者：王文姣 杜军 肖鹏 Wang Wenjiao;Du Jun;Xiao Peng(Zhejiang Medo Intec Co.,Ltd.,Hangzhou,Zhejiang 311107,China;Zhejiang Meiyang International Engineering Design Co.,Ltd.,Hangzhou,Zhejiang 310015,China)

机构地区：[1]浙江美渡智慧医药科技有限公司,浙江杭州311107 [2]浙江美阳国际工程设计有限公司,浙江杭州310015

出　　处：《化工与医药工程》2024年第4期31-35,共5页Chemical and Pharmaceutical Engineering

摘　　要：细胞和基因治疗(Cell and Gene Therapy,简称CGT)近年来获得快速发展。由于CGT的起始物料差异大,工艺流程具有特异性等特点,造成研发数据完整性合规难度大等的问题。文章介绍了一种根据CGT研发特点而开发的计算机化系统:它整合了电子实验记录本(ELN)及部分实验室信息管理系统(LIMS)的功能,可最大程度确保研发人员的操作、记录符合GMP规范,确保研发数据真实可靠,符合数据完整性和新药申报要求。Cell and Gene Therapy(CGT)has developed rapidly in recent years.Due to the large differences in starting materials and the specificity of the CGT process,it is difficult to comply with the integrity of research and development data.This paper introduces a computerized system developed according to the characteristics of CGT research and development:it integrates the functions of electronic Laboratory Record Book(ELN)and part of the Laboratory Information Management System(LIMS),which can ensure that the operation and recording of the R&D personnel comply with GMP regulations to the maximum extent,ensure that the R&D data is true and reliable,and meet the data integrity and new drug application requirements.

关 键 词：数据完整性 电子实验记录本(ELN) 细胞和基因治疗(CGT) GMP合规 

分 类 号：TP309.3[自动化与计算机技术—计算机系统结构]