制药行业SCADA审计追踪功能探讨  

Discussion on SCADA Audit Trail in Pharmaceutical Industry

作　　者：刘圣林 包卿 Liu Shenglin;Bao Qing(Mingdu Zhiyun(Zhejiang)Technology Co.,Ltd.,Hangzhou Zhejiang 310012)

机构地区：[1]明度智云(浙江)科技有限公司,浙江杭州310012

出　　处：《中国仪器仪表》2023年第11期52-56,共5页China Instrumentation

摘　　要：制药行业SCADA系统信息化的建设是一个系统性工程,需要更多地考虑功能、审计和法规符合性。同时,随着监管机构对计算机化系统验证的关注提升,制药行业信息化数据完整性的覆盖范围,已经逐步从实验室管理扩大到行业生产和过程控制。SCADA作为制药行业生产过程信息化重要组成部分,其实现了生产计划调度、生产过程监控、设备与仪表数据采集以及报警趋势数据统计分析等核心功能,基于此对其审计追踪功能也提出了更高的要求。本文阐述了数据完整性和审计追踪的定义和重要性,结合相关法规和最佳实践,提出了一种SCADA系统审计追踪的设计方案,以期为制药行业SCADA系统信息化建设合规性提供完整解决方案。The construction of SCADA system informatization for data acquisition and monitoring software in the pharmaceutical industry is a systematic project,which requires more consideration of function,audit and regulatory compliance.At the same time,with the increasing attention of regulatory authorities to the verification of computerized systems,the coverage of information data integrity in the pharmaceutical industry has gradually expanded from laboratory management to industry production and process control.SCADA is an important part of production process informatization in pharmaceutical industry.It realizes the core functions such as production planning and scheduling,production process monitoring,equipment and instrument data collection,and alarm trend data statistical analysis,based on this,higher requirements are put forward for its audit tracking function.This paper describes the definition and importance of data integrity and audit trail,and proposes a design scheme of audit trail for SCADA system combined with relevant regulations and best practices,in order to provide a complete solution for the compliance of SCADA system information construction in the pharmaceutical industry.

关 键 词：GMP 计算机化验证 SCADA 审计追踪 数据完整性 

分 类 号：F239.1[经济管理—会计学] F426.72[经济管理—国民经济] TP311.13[自动化与计算机技术—计算机软件与理论]