《GAMP 5 Guide 2nd Edition 阅读笔记 - *》系列以 ISPE 发行的英文原版为准,本文不含任何执导、建议,本文作者不对任何组织、团体负责。
ISPE: (International Society for Pharmaceutical Engineering) 国际制药工程协会 [国际] [非强制] 官方网站 参考文献 1.ispe.org. GAMP 5 Guide 2nd Edition. :ispe.org, . [Online]. Available: ispe.org/publications/g GAMP 5 Guide 2nd Edition编辑...
GAMP 5 Guide 2nd Edition 第三节分类 第一类：基础设施类软件 基础设施类软件通过整合形成运行与支持应用与服务的集成环境。分为两类：一是操作系统、数据库管理软件、编程语言、中间件、统计编程工具、电子表格软件等；二是网络监控软件、批处理任务调度工具、安全软件、防病毒软件、系统配置管理工具。第...
GAMP 5 途 用 A Risk-Based Approach to Compliant GxP 业 Computerized Systems 商 何 Second Edition 任 于 用 使 禁 严 流 交 习 学 供 仅 料 资 本 翻译:杨勇 校对:杨勇 排版:杨勇 水平有限,有纰漏之处,望大家谅解并给予修正 1 / 333 本资料仅供学习交流严禁使用于任何商业用途! ISPE Gamp !
To use the GAMP5 Template, start by installing our QC Template Launcher app from the Atlassian Marketplace. Step 2: Purchase a License from the QC Store Visit our store to purchase a license for the GAMP5 Guide, 2nd Edition Template for Confluence Cloud. Once you complete your ...
A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)基于风险的GXP...
Computer system validation & maintenance based on GAMP 5 2nd Validation and maintenance of computerized systems based on GAMP 5 Second Edition in GxP enviornment评分:3.8,满分 5 分440 条评论总共2 小时8 个讲座所有级别当前价格: US$10.99原价: US$19.99 讲师: Adrian Krzesniak 评分:3.8,满分 5 分3....
GAMP 5 Guide 2nd Edition 中文版《GAMP5(良好自动化生产实践规范)指南》第二版---GAMP 5 Guide 2nd Edition 中文版
GAMP Lab Systems Guide:Second Edition Since the release of version 5 of the GAMP guide (10), the 2005 version of the laboratory GPG has been out of step with the risk-based approach taken by the former publication. The GAMP forum made a decision to revise the document and publish ...
位置 GAMP 5 Guide 2nd Edition Page 21 第2.2节 Computerized System 计算机化系统 A computerized system consists of the hardware, software, and network components, together with the controlled functions and associated documentation (see also the GAMP Good Practice Guide: IT Infrastructure Control and ...