基于工作流和本体建模的GMP文档管理系统研究

STUDY ON GMP FILE MANAGEMENT SYSTEM BASED ON WORKFLOW AND ONTOLOGY MODELING TECHNOLOGY

GMP(药品生产质量管理规范)是制药行业质量管理的依据,对GMP文档进行管理是制药企业的一项重要任务。然而,目前采用的一些基于手工方式或利用传统的GMP文档管理系统来管理GMP文档,还存在业务流程不能与文档的紧密相关、系统的重构性和可扩充性较差等问题。为解决这些问题,首先讨论了GMP文档管理的特点和复杂性及现有一些方法的不足,然后提出一种基于工作流和本体建模的GMP文档管理系统框架,接着详细分析了各组成部分主要功能及各子系统的具体实现。

GMP is a criterion of drug quality management. It is an important task to manage GMP files in drug production enterprises. However, the traditional methods which use handwork or traditional GMP file management system still have some problems such as the unclose relation between the operation flow and the GMP files or the poor abilities of system reconfiguration and extension. To solve these problems, the characteristic and complexity of GMP management are discussed and a framework of GMP file management system based on workilow and ontology modeling technology is presented. Also the main functions of components in the framework and the implement methods of subsystems are analyzed in detail.