通用的數(shù)據(jù)完整性(數(shù)據(jù)可靠性)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.藥品質(zhì)量管理體系(QMS )的實(shí)施應(yīng)貫穿活性

2、藥物成分和醫(yī)藥產(chǎn)品的 整個(gè)生命周期的不同階段,應(yīng)該鼓勵(lì)使用科學(xué)和基于風(fēng)險(xiǎn)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

3、, and a fundamental 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(shí)信息是可靠的，這些決策的事件和動(dòng) 作應(yīng)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(guān)鍵， 和良好設(shè)計(jì)的藥品質(zhì)量管理體系在第6節(jié)中討論必基本組成部分。7.3 The application of GDocPs may vary depending on the medium used to record the data (ie. physica

4、l 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

5、適當(dāng)?shù)恼{(diào)整，但原則對(duì)于兩種方法均適用。本小節(jié)將介紹這些 關(guān)鍵的原則，第8和9小節(jié)將探索這些涉及到紙質(zhì)和電子記錄保存的 原則。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, t

6、hese expectations ensure 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(guān)鍵概念總結(jié)如下：可追溯、清晰、同步、原始、 準(zhǔn)確。本表格添加了以下內(nèi)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。7.5 Basic DI principles applicable to both paper and electronic systems (ALCOA +):基本的D

7、I原則(ALCOA +),適用于紙質(zhì)和電子系統(tǒng)：Data 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 / function, is in part to demonstrate that the function was performed by trained and quali

8、fied personnel. This applies to changes made to records as well: corrections, deletions, changes, etc.應(yīng)可以確定執(zhí)行記錄任務(wù)的個(gè)人。需要用文檔證明,執(zhí)行任務(wù)，運(yùn) 行的人是經(jīng)過(guò)培訓(xùn)合格的人員。這也適用于記錄的變更；修正、刪 除、更改等。Legble 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 inform

9、athn that would be required to be considered Complete, including all 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 suit

10、able application is important to the 'availability' of the record.所有記錄必須清晰,信息必須可讀,以便于任何使用.這適用于必 須被認(rèn)為是完整的所有信息，包括所有的原始記錄或條目。電子數(shù) 據(jù)的“動(dòng)態(tài)隴性(能夠搜然、儻詢、趨勢(shì)分析等)對(duì)記錄的內(nèi)容和 意義很重要口能夠使用合適應(yīng)用程序與數(shù)據(jù)交互時(shí)記錄的何用性” 很重要6Contemporaneous 同步The evidence of actions, events or decisions shoutd be recorded as they take place.

11、This documentation should serve as an accurate attestation of what was done, or what was decided and why, ie what influenced the decision at that time, 動(dòng)作、事件或決策的證據(jù)應(yīng)在他們發(fā)生時(shí)被記泉。這個(gè)文檔可作為個(gè)準(zhǔn)確的證據(jù)，來(lái)記錄做了什么或決定什么.為什么這么做, 如；是什么影響了當(dāng)忖的決定。Original 原始The original record can be described as the first-capture of infor

12、mation, whether recorded on paper (static) or el&ctronically(usually dynamic, depending on the complexity of the system)Jnformation ihat is originally captured in a dynamic state should remain available in that state.原始記錄可以被認(rèn)為是信息的首次捕獲，可記錄在紙上(靜態(tài))也 可以是電子記錄(通常是動(dòng)態(tài)的，取次于系統(tǒng)的復(fù)朵程度最初 在動(dòng)態(tài)中捕獲的信息應(yīng)保持可用的狀態(tài).-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 Sy