摘要
数据完整性的要求越来越成为各个国家药品监管部门的检查重点,而计算机化系统验证是实现数据完整性的重要一环。本文参考国内外法规和指南,结合工作经验,从概念,计算机化系统验证项目,质量风险管理工具的运用,到验证的原则和方法进行探讨。
Data integrity requirements are increasingly becoming the focus of inspection by drug regulators in various countries, and computerized system validation is an important part of achieving data integrity. This paper refers to domestic and foreign regulations and guidelines, combined with work experience, discussing from the concept, computerized system validation items, the use of quality risk management tools, to validation principles and methods.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2017年第12期1818-1821,共4页
Chinese Journal of Pharmaceuticals
关键词
数据完整性
计算机化系统
验证
data integrity
computerized system
validation
