通用的数据完整性（数据可靠性）的原则和要素

7． GENERAL DATA INTEGRITY 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 Management System (QMS) should be implemented throughout the different stages of the life cycle of the Active Pharmaceutical Ingredients and medicinal products and should 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 well informed and to verify that the information is reliable, the events or actions that informed those decisions should be well documented. As such, Good Documentation Practices (GDocPs) are key to ensuring data integrity, and a fundamental 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 vary depending on the medium used to record the data (ie. physical vs. electronic records), but the principles are applicable to both. This section will introduce those key principles and following sections (8 & 9) will explore these principles relative to documentation in both paper-based and electronic-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 are summarised 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 expectations ensure that events are properly documented and the data can be used to support informed 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 both paper 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 appropriately applied to all applicable areas of GMP and GDP-related activities, along with other supporting elements of a Pharmaceutical Quality Management System, the reliability of the information used to make critical decisions regarding drug products 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。

GMP办公室翻译组

译者：风中等待

校对：Owen

欢迎加入GMP办公室翻译组QQ群：307361958

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