摘要
国际药监机构和组织针对计算机化系统应用合规性和数据可靠性出台了一系列法规和指南,制药企业需要建设一套完整的管理和合规体系来保障落实。本文探讨了制药企业计算机化系统管理及合规体系建设的一般方法,系统性提升计算机化系统应用合规性与数据可靠性水平,持续满足药品监管要求。
International drug regulatory agencies and organizations have issued a series of regulations and guidelines for the compliance and data reliability of computerized systems.Pharmaceutical enterprises need to establish a complete set of management and compliance framework to ensure the implementation.This paper discusses the general method to establish the management and compliance framework of computerized system in pharmaceutical enterprises,which can systematically improve the level of compliance and data reliability management of computerized systems,and continuously meet the requirements of pharmaceutical supervision.
作者
方红军
FANG Hongjun(Chia Tai Tianqing Pharmaceutical Group Co.,Ltd.,Nanjing 211100)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2021年第3期414-420,共7页
Chinese Journal of Pharmaceuticals
关键词
计算机化系统
合规
验证
数据可靠性
computerized system
compliance
verification
data reliability
