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 !
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 …
ISPE GAMP 5 Second Edition therefore embraces and reflects:1、Increased importance of service providers, which includes encouraging regulated companies to maximize supplier involvement to leverage knowledge, experience, and documentation where possible 强调供应商的重要性,鼓励受监管的公司最大程度与供应商在...
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 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...
A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)基于风险的GXP...
The appendixes of the second edition GPG are listed below: 1. Comparison of USP <1058> and GAMP GPG 2. Categories of Software 3. System Description 4. Application of EU Annex 11 to Computerized Lab Systems 5. Data Integrity 6. Definition of Electronic Records and Raw Data ...
GAMP 5 Guide 2nd EditionPage 128 第三节 Categories of Software 分类 Category 1 –Infrastructure Software 第一类:基础设施类软件 Infrastructure elements link together to form an integrated environment for running and supporting applications and services. ...