通用的数据完整性的原则和要素

1、通用的数据完整性（数据可靠性）的原则和要素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

2、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。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 f

3、undamental 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。The application of GDocPs may vary depending on the medium used to record the data (ie. physical vs. elect

4、ronic 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

5、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。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 ensu

6、re 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。Basic DI principles applicable to both paper and electronicsystems (ALCOA +):基本的DI原则(ALCOA +)，适用于纸质和电子系统：Dat

7、a Integrity Attribute 数据完整性属性Requirement要求Attributable可追溯It should be possible to identify the individual who performed the recorded task. The need to document who performed the task f function, is in part to demonstrate that the function was performed by trained and qualified personnel. This applie

8、s to changes made to records as well: corrections, deletions, changes, etc.应可以确定执行记录任务的个人，需要用文档证明，执行任务/运 行的人是经过珞训合格的人员。这也适用于记录的变更;修正、删 除、更改等。Legible清晰All records must be legible - the information must be readable in order for it to be of any use. This applies to all information that would be require

9、d to be considered Complete, including aid Original records or entries. Where the dynamic nature of electronic data (the ability to search, query, trend, etc) is important to the content and meaning of the record, the ability to interact with the data using a suitable application is important to the

10、 availability of the record.所有记录必须清晰,信息必须口J读.以便于任何使用。这适用于必 须被认为姑完整的所有信息，包括所有的原始记录或条目电子数 据郦动态嘲性(能够搜索、径询、趋势分析等)对记荥的内容和 意义很里要n能够使用合适应用程序与数据交互耐记录的-可用性” 很重要6Contemporaneous 同步The evidence of actions, events or decisions should be recorded as they take place. This documentation should serve as an accurate

11、 attestation of what was done, or what was decided and why, ie what influenced the decision at that time,动作、宰件或决策的证据应在他们发生时被i己泉。这个文档可作为 一个准确的证据,来记录做了什么或决定r什么,为什么这么做, 如；是什么影响了当时的决定。Original原始The original record can be described as the first-capture of information, whether recorded on paper (static) o

12、r electronically(usually dynamic, depending on the complexity of the system)Jinformation that is originally captured in a dynamic state should remain available in that state.原始记录可以被认为是信恩的首次捕获,可记录在纸上静态)也 可以是电子包录(通常是动态的，取决于系统的复杂程度)。最初 在动态中捕获的信息应保持可用的状态。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 Syste