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发表于 2022-6-12 18:53:34
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本帖最后由 xjzc 于 2022-6-12 18:58 编辑
Data Integrity by Design is the concept that data integrity must be incorporated from the initial planning of a business process through to the implementation, operation, and retirement of computerized systems supporting that business process. It promotes the application of critical thinking to identify how data flows through the business process and to proactively assess and mitigate risks across both the system and data lifecycles. It emphasizes data integrity as foundational to protecting patient safety and product quality.
数据完整性设计的概念是，数据完整性必须纳入从业务流程的最初规划，到实施，操作和退役的计算机化系统支持的业务流程。它促进了批判性思维的应用，以确定数据如何通过业务流程流动，并主动评估和减轻系统和数据生命周期中的风险。它强调数据完整性是保护患者安全和产品质量的基础。
This ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design supports organizations as they embrace and implement a holistic approach by leveraging data governance and knowledge management activities to drive continual improvement in data integrity. The Guide promotes a patient-centric mindset, focusing resources and management attention on quality best practices that inherently facilitate meeting regulatory compliance requirements.
这个 ISPE GAMP RDI 良好做法指南: 数据完整性设计支持组织，因为他们拥护和实施一个整体的方法，利用数据治理和知识管理活动，以推动数据完整性的持续改善。《指南》提倡以病人为中心的思维模式，将资源和管理层的注意力集中在质量最佳做法上，这些做法本质上有助于满足守规的要求。
This Guide provides a bridge between the system lifecycle approach defined in ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems, and the data lifecycle approach in the ISPE GAMP® Guide: Records and Data Integrity. Data integrity can only be achieved when both lifecycle approaches are adopted, understood, and actively managed.
本指南在 ISPE GAMP 5: 符合 GxP 计算机系统的基于风险的方法中定义的系统生命周期方法和 ISPE GAMP 指南: 记录和数据完整性中的数据生命周期方法之间提供了一个桥梁。只有采用、理解和积极管理两种生命周期方法，才能实现数据完整性。
Several new areas are covered in this Guide. One such topic is Knowledge Management (KM), which can be considered the link between data governance and quality risk management. KM enables organizations to make decisions more efficiently and encourages an organizational culture of learning.
本指南涵盖了几个新的领域。其中一个主题是知识管理(KM) ，它可以被认为是数据治理和质量风险管理之间的联系。知识管理使组织能够更有效地作出决策，并鼓励组织文化学习。
Many instrument devices such as filter integrity testers and pH meters have moved from a simple display of the measured value to temporarily storing electronic records. This evolution has resulted in increasing regulatory awareness of the data integrity risk posed by such devices lacking the sophisticated technical controls inherent in larger computerized systems. The ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design offers a pragmatic, practical approach to the identification and remediation of the risks, and endorses the adoption of working practices to protect and review the electronic records.
许多仪器设备，如过滤器完整性测试仪和 pH 计已经从简单的显示测量值转变为临时存储电子记录。这种演变导致监管部门日益认识到这种设备缺乏大型计算机化系统固有的复杂技术控制所构成的数据完整性风险。《 ISPE GAMP RDI 良好做法指南: 设计的数据完整性》为识别和补救风险提供了一种务实、实用的方法，并认可采用工作实践来保护和审查电子记录。
In an industry first, members of the Computer Software Assurance (CSA) team (responsible for working with the FDA to develop the draft guidance on this topic) have collaborated closely with ISPE GAMP® subject matter experts to create an appendix to the ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design. This appendix details the key concepts of CSA and provides illustrative case studies of its application.
在一个行业的第一，计算机软件保证(CSA)团队的成员(负责与 FDA 合作开发这个主题的指导草案)与 ISPE GAMP 主题专家密切合作，创建了 ISPE GAMP RDI 良好实践指南的附录: 设计的数据完整性。本附录详细介绍了 CSA 的关键概念，并提供了其应用的说明性案例研究。
This Guide is positioned under the ISPE GAMP® Guide: Records and Data Integrity series and replaces and significantly expands upon the ISPE GAMP® Good Practice Guide: Electronic Data Archiving from 2007.
本指南定位于 ISPE GAMP 指南: 记录和数据完整性系列，取代并大大扩展了 ISPE GAMP 良好实践指南: 从2007年开始的电子数据归档。
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