基于CSV要求对制药企业的计算机化系统分类与管理实践

Practice of Classification and Management of Computerized Systems in Pharmaceutical Enterprises Based on CSV Requirement

基于中国药品生产质量管理规范附录计算机化系统要求,探讨适当的计算机化系统分类与日常管理细节。在中国药品生产质量管理规范的要求下,根据企业不同种类计算机系统的特点,形成不同的分类依据,再根据适当的分类方法将不同的设备仪器分到恰当类别中,是一种便于制药企业的计算机化系统分类及日常管理,降低生产质量风险,保证数据可靠性的有效手段。

Based onthe annex in Chinese Good Manufacturing Practice-Computerized System,the appropriate classification and daily management details of computerized system were discussed.With the requirements of Chinese Good Manufacturing Practice,and according to the characteristics of different kinds of computerized systems used in enterprises,in this paper,different classification basis were formed.Then different equipment and instruments were classified into specific categories according to appropriate classification methods,which is an effective means to facilitate the classification and daily management of computerized system used in pharmaceutical enterprises.This method can reduce the productive quality risk and ensures the data integrity.