药品生产质量文件的计算机管理

Computer Management of Quality Document For Drug Production

文章阐明了药品生产质量文件的作用、分类、主要管理过程及采用计算机管理的必要性,介绍了作者开发的GMP质量文件管理软件系统的设计方案与主要特点,为制药企业质量文件的管理提供了一种科学、规范且高效的方法。

This article expounds the function,classification,the main management process of quality document in drug production and the necessity of using computer management system.A design scheme and the main feature of a software system for GMP quality document management the authors developed are introduced.This system supplies a scientific,normative and high-effective method for quality document management in drug production enterprise.