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所在平台: Udemy |
课程主页: https://www.udemy.com/course/plc-validation/
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课程名称：PLC验证 课程概述：本课程旨在帮助参与者理解与cGXP计算机系统相关的常见错误。课程包含多个录制的讲座。第一讲主要讲解人机界面（HMI）、可编程逻辑控制器（PLC）和监控与数据采集系统（SCADA）的基础知识，包括HMI的基本理解、HMI的工业用途、HMI的优点、PLC的简要了解、PLC中URS的主要考虑因素、PLC的缺点讨论，以及SCADA的基本理解和组成部分。 接下来的讲座专注于计算机系统验证的基础知识，内容包括该主题的重要性、医药4.0的介绍、验证的目的与范围、GAMP5、硬件和软件的分类、验证策略、URS、FRS、FAT、SAT、IQ、OQ、PQ、UAT的理解，以及验证计划与验证主计划的比较（VR与VMR）和GAMP 5的主要变化。 PLC验证部分的第一节讲座介绍了相关概念、PLC及其验证策略、GXP计算机系统的类型、验证的要求、追踪矩阵的理解、功能风险评估（FRA）的要素、基础设施风险评估、过程控制系统的验证要求、GXP与非GXP系统的识别、基于系统复杂度的关键性，以及PLC逻辑的验证。 最后一节讲座是PLC验证的第二部分，内容包括对第一节内容的快速回顾、不同测试策略的理解、白盒测试与黑盒测试的简要介绍、在PLC验证中采用的敏捷测试方法、敏捷方法与瀑布方法的区别、验证与确认的区别、QTP（快速测试专业版）与手动测试的比较、手动测试的各个阶段以及系统退役计划。
The participants of the course will understand the common errors made related to cGXP computerized systems. The course consists of different recorded lectures. The first lecture is designed to teach the basics about HMI, PLC, and SCADA. This lecture includes a brief understanding of HMI, Industrial Usage of HMI, Benefits of HMI, a Brief understanding of PLC, Major considerations of URS in PLC, a Discussion on drawbacks of PLC, a Brief understanding of SCADA and Components of SCADA.A Separate lecture on the basics of computerized system validation. This lecture briefly includes the importance of the topic, Introduction to Pharma 4.0, Purpose and Scope, GAMP5, Categories of Hardware and software, Validation strategies, Understanding URS, FRS, FAT, SAT, IQ, OQ, PQ, UAT, Validation plan Vs Validation Master Plan- VR Vs VMR and Major changes in GAMP 5.The lecture on PLC validation part (Session)-1 is designed to include a brief introduction of the concept, PLC, validation strategy, Types of GXP computerized systems, Requirements for Validation, Understanding Traceability Matrix, Elements of Functional Risk Assessment (FRA), Infrastructure Risk Assessment, Process Control System validation requirements, Identifying GXP and non-GXP systems, Criticality based on system complexity and Validation of PLC logic.The last lecture on PLC validation Part (Session)-II is designed to include a quick recap from Session - 1, an Understanding of different test strategies, a Brief on white box and black box testing, Agile testing approach during PLC validation.Difference between the Agile Approach and Waterfall approach, Verification vs. validation, QTP (Quick Test Professional) and Manual testing, Stages of Manual testing, and System Retirement Plan
