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目的 开发一套简单、实用、扩展性强的过程控制管理系统 ,应用于我省药品GSP认证工作。方法 用C ++Builder,以SQLserver 2 0 0 0为平台开发一套客户 /服务器 (C/S)模式的系统 ,通过该系统实现对申请GSP认证企业的申报资料、认证申请、资料形式审查、资料受理、认证收费、资料技术审查、现场检查方案制订、检查员抽选、现场检查报告的审核、GSP认证结果网上公示、审批、发证、公告等GSP认证的全过程进行管理。结果 省食品药品监督管理局、省药品审评认证中心及佛山、东莞等2 0个地市的GSP认证工作站都使用该系统对GSP认证工作进行管理 ,目前通过该系统已实现对 110 0多家批发、连锁企业 ,5 0 0 0多家零售企业的GSP认证管理。结论 药品GSP认证管理系统的开发及应用促进了认证管理工作的规范化、信息化 ,提高了工作效率 ,保证了GSP认证工作的公开、公平、公正。
Objective To develop a simple, practical and extensible process control management system which is applied to GSP certification in our province. Methods C ++ Builder and SQLserver 2000 are used to develop a client / server (C / S) mode system. Through this system, application documents, certification application, data type examination, Data acceptance, certification fees, data technology review, on-site inspection program development, inspector lottery, on-site inspection report audit, GSP certification results online publicity, approval, certification, announcement and other GSP certification of the whole process of management. Results The provincial Food and Drug Administration, the provincial drug review and certification center and Foshan, Dongguan and other cities in 20 GSP certification workstations using the system to manage GSP certification, the current system has been achieved through more than 110 0 Wholesale, Franchise, GSP Certification Management for more than 500 retailers. Conclusion The development and application of drug GSP certification management system has promoted the standardization and informationization of certification management and improved the work efficiency, ensuring the openness, fairness and fairness of GSP certification.