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所在平台: Udemy |
课程主页: https://www.udemy.com/course/data-integrity-for-computerized-systems-in-gxp-environment/
课程评论：没有评论
课程名称：GxP环境中计算机系统的数据完整性 课程概述： 该课程旨在探讨与计算机系统生命周期相关的数据完整性的各个方面。课程深入分析基于GAMP 5第五版及其他指导方针的数据完整性问题，并收集FDA及地方监管机构常见数据完整性发现的信息。 课程内容： 1. 系统设计中的数据完整性 - 确保数据完整性 - 账户和访问权限 - 数据安全性 - 审计跟踪 - 备份与恢复 2. 系统运行中的数据完整性 - 操作流程 - 定期审查 - 用户访问审查、账户使用审查 - 审计跟踪审查 3. 系统退役中的数据完整性 - 迁移 - 存档 - 销毁（保留和销毁） 4. 数据完整性评估 - 审计跟踪 - 报告 - 备份和恢复 - 系统安全性 - 数据存储与导出 - 账户和访问权限 计算机系统的数据完整性是指数据在其生命周期内的准确性、可靠性和一致性。它确保数据在创建或输入系统的那一刻直到访问、修改或删除时的完整性、未被篡改，且保持完整。在医疗、金融和合规监管等领域，维护数据完整性至关重要，因为准确的数据对决策和遵守法规至关重要。为了保护计算机系统中的数据完整性，通常采用加密、访问控制、验证检查和备份程序等多种措施。
The goal of the courseExplore all aspects related to data integrity in the system's lifecycleDive deep into data integrity aspects related to computer system validation based on GAMP 5 edition 5 and other guidelinesGather information about common data integrity findings from the FDA and local regulatory bodiesScope of the courseData integrity in system designEnsuring Data IntegrityAccounts & Access RightsData securityAudit TrailBackup & RestoreData integrity in system operationOperational ProcessesPeriodic ReviewUser Access Review, Account Usage ReviewAudit Trail ReviewData Integrity in System RetirementMigrationArchivalDestruction (Retention, Destruction)Data Integrity AssessmentAudit trailReportingBackup and restoreSystem SecurityData storage and exportAccounts & Access RightsData integrity for computerized systems refers to the accuracy, reliability, and consistency of data throughout its lifecycle. It ensures that data is complete, unaltered, and remains intact from the moment it is created or entered into a system until the time it is accessed, modified, or deleted. Maintaining data integrity is crucial for ensuring the trustworthiness and quality of information in computer systems, especially in sectors like healthcare, finance, and regulatory compliance where accurate data is essential for decision-making and compliance with regulations. Various measures, such as encryption, access controls, validation checks, and backup procedures, are employed to preserve data integrity in computerized systems.
