摘要
根据GxP(GMP、GLP、GCP、GDP)的要求,论述了国内外计算机化系统在验证、日常维护、安全、改变控制、人员、电子签名和电子记录方面的管理。
Based on the requirements ofGxP （GMP, GLP, GCP and GDP）, in this article, the management of computerized systems at home and abroad in the aspects of verification, daily maintenance, safety, control change, operator, electrical sign and electrical record was described.
出处
《医药工程设计》
2006年第6期22-25,共4页
Pharmaceutical Engineering Design
关键词
计算机化系统
质量管理
Computefizedsystem Quality management
