通用的數(shù)據(jù)完整性的原則和要素

1、通用的數(shù)據(jù)完整性（數(shù)據(jù)可靠性）的原則和要素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.藥品質量管理體系(QMS)的實施應貫穿活性藥物成分和

2、醫(yī)藥產(chǎn)品的 整個生命周期的不同階段，應該鼓勵使用科學和基于風險的方法。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).為確保決策能很好的獲知，證實信息是可靠的，這些決策的事件和動 作應是有據(jù)可查的。同樣，良好的文檔規(guī)范是確保數(shù)據(jù)完整的關鍵， 和良好設計的藥品質量管理體系(在第6節(jié)中討論)的基本組成部分。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.良好文檔規(guī)范可根據(jù)用于記錄數(shù)據(jù)的方法(例如：物理的與電子的記 錄)做適當?shù)恼{整，但原則對于兩種方法均

5、適用。本小節(jié)將介紹這些 關鍵的原則，第8和9小節(jié)將探索這些涉及到紙質和電子記錄保存的 原則。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.良好文檔規(guī)范的一些關鍵概念總結如下：可追溯、清晰、同步、原始、 準確。本表格添加了以下內容：完整、一致、持久和有效。這些原則 合在一起，確保事件被正確的記錄和數(shù)據(jù)的可用性，以幫助作出明智 的決定。Basic DI principles applicable to both paper and electronicsystems (ALCOA +):基本的DI原則(ALCOA +)，適用于紙質和電子系統(tǒng)：Dat

7、a Integrity Attribute 數(shù)據(jù)完整性屬性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.應可以確定執(zhí)行記錄任務的個人，需要用文檔證明，執(zhí)行任務/運 行的人是經(jīng)過珞訓合格的人員。這也適用于記錄的變更;修正、刪 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.所有記錄必須清晰,信息必須口J讀.以便于任何使用。這適用于必 須被認為姑完整的所有信息，包括所有的原始記錄或條目電子數(shù) 據(jù)酈動態(tài)嘲性(能夠搜索、徑詢、趨勢分析等)對記滎的內容和 意義很里要n能夠使用合適應用程序與數(shù)據(jù)交互耐記錄的-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,動作、宰件或決策的證據(jù)應在他們發(fā)生時被i己泉。這個文檔可作為 一個準確的證據(jù),來記錄做了什么或決定r什么,為什么這么做, 如；是什么影響了當時的決定。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.原始記錄可以被認為是信恩的首次捕獲,可記錄在紙上靜態(tài))也 可以是電子包錄(通常是動態(tài)的，取決于系統(tǒng)的復雜程度)。最初 在動態(tài)中捕獲的信息應保持可用的狀態(tài)。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