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

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.