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所在平台: Udemy |
课程主页: https://www.udemy.com/course/mobile-application-validation-in-gxp/
课程评论：没有评论
课程名称：基于GAMP 5的GxP环境中的移动应用验证 课程概述：本课程旨在探讨移动应用验证的特定方面，了解移动应用作为计算机系统运作与作为医疗设备的移动应用之间的区别。课程还将讲解连接类型在验证过程中的重要性。 课程范围： - 引言 - 移动应用的类型 - 移动应用生命周期 - 移动应用架构、设备连接与组件 - 移动应用验证的特定方面 - 移动应用案例研究 移动设备的验证：移动设备可以作为独立系统运行，或集成到其他系统中，这就需要定制的验证流程。此外，移动应用具有特定的要求和风险，CSV（计算机化系统验证）专家必须对此有所了解。一个关键方面是理解移动设备如何存储数据和连接数据库。 在GxP（良好实践）环境中的移动验证是一项重要过程，旨在确保用于制药、医疗保健及其他受监管行业的移动应用的完整性、安全性和合规性。GxP指南，如GMP（良好生产规范），要求对移动应用进行严格的验证程序。该验证过程包括全面测试，以确认移动应用是否按预期运行、符合监管标准、并保持数据的准确性和安全性。正确记录验证活动，包括测试协议、结果和偏差，对于证明遵守GxP法规至关重要。遵循这些验证实践确保了在GxP环境中使用的移动应用是可靠、安全和适合其预期用途的，有助于提高受监管行业产品和服务的整体质量和安全性。
The goal of the courseExplore specific aspects of mobile application validationFind out the difference between a mobile application functioning as a computerized system and a medical application acting as a mobile device.Learn why the type of connectivity is important during validation.Scope of the courseIntroductionTypes of mobile appsMobile application life cycleMobile app architectures, device connectivity & componentsSpecific aspects of mobile application validationSample mobile application case studiesValidation of Mobile Devices: Mobile devices can function as standalone systems or be integrated into other systems, necessitating tailored validation processes. Furthermore, mobile applications have specific requirements and risks that CSV specialists must be aware of. A critical aspect is understanding how mobile devices store data and connect to databases.Mobile validation in GxP (Good Practice) environments is a crucial process to ensure the integrity, security, and compliance of mobile applications used in pharmaceutical, healthcare, and other regulated industries. GxP guidelines, such as GMP (Good Manufacturing Practice), require rigorous validation procedures for mobile applications. This validation process involves thorough testing to confirm that mobile applications function as intended, meet regulatory standards, and maintain data accuracy and security. Proper documentation of validation activities, including testing protocols, results, and deviations, is essential to demonstrate compliance with GxP regulations. Adhering to these validation practices ensures that mobile applications used in GxP environments are reliable, safe, and suitable for their intended use, contributing to the overall quality and safety of products and services in regulated industries
