7． GENERAL DATAINTEGRITY PRINCIPLES AND ENABLERS 通用的数据完整性的原则和要...

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7． GENERAL DATAINTEGRITY PRINCIPLES AND ENABLERS
通用的数据完整性的原则和要素

本文为PIC/S《GMP/GDP环境中数据管理和数据可靠性规范》第七章翻译稿。由GMP办公室翻译组牵头翻译，译者：风中等待，校对：Owen。GMP办公室后续将陆续推送关于PIC/S《GMP/GDP环境中数据管理和数据可靠性规范》的翻译稿，欢迎加入GMP办公室翻译组QQ群：307361958，参与更多文献翻译。

7.1 The Pharmaceutical Quality ManagementSystem (QMS) should be implemented throughout the different stages of the lifecycle of the Active Pharmaceutical Ingredients and medicinal products andshould encourage the use of science and risk-based approaches.
药品质量管理体系（QMS）的实施应贯穿活性药物成分和医药产品的整个生命周期的不同阶段，应该鼓励使用科学和基于风险的方法。

7.2 To ensure that decision making is wellinformed and to verify that the information is reliable, the events or actionsthat informed those decisions should be well documented. As such, GoodDocumentation Practices (GDocPs) are key to ensuring data integrity, and afundamental part of a well designed Pharmaceutical Quality Management System(discussed in section 6).
为确保决策能很好的获知，证实信息是可靠的，这些决策的事件和动作应是有据可查的。同样，良好的文档规范是确保数据完整的关键，和良好设计的药品质量管理体系（在第6节中讨论）的基本组成部分。

7.3 The application of GDocPs may varydepending on the medium used to record the data (ie. physical vs. electronicrecords), but the principles are applicable to both. This section willintroduce those key principles and following sections (8 & 9) will explorethese principles relative to documentation in both paper-based andelectronic-based record keeping.
良好文档规范可根据用于记录数据的方法（例如：物理的与电子的记录）做适当的调整，但原则对于两种方法均适用。本小节将介绍这些关键的原则，第8和9小节将探索这些涉及到纸质和电子记录保存的原则。

7.4 Some key concepts of GDocPs aresummarised by the acronym ALCOA: Attributable, Legible, Contemporaneous,Original, Accurate. To this list can beadded the following: Complete,Consistent, Enduring and Available (ALCOA+5). Together, these expectationsensure that events are properly documented and the data can be used to supportinformed decisions.
良好文档规范的一些关键概念总结如下：可追溯、清晰、同步、原始、准确。本表格添加了以下内容：完整、一致、持久和有效。这些原则合在一起，确保事件被正确的记录和数据的可用性，以帮助作出明智的决定。

7.5 Basic DI principles applicable to bothpaper and electronic systems (ALCOA +):
基本的DI原则 (ALCOA +)，适用于纸质和电子系统：


7.6 If these elements are appropriatelyapplied to all applicable areas of GMP and GDP-related activities, along withother supporting elements of a Pharmaceutical Quality Management System, thereliability of the information used to make critical decisions regarding drugproducts should be adequately ensured.
如果这些要素被适当使用于GMP和GDP相关活动的所有适用领域，连同药品质量管理体系的其他支持要素，用于药品关键决定的信息的可靠性应被充分保证。

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