GMP数据完整性

MHRA发布GMP数据完整性博文：老调新谈(第1部分)

原创2015-08-05LucyWang洛施德GMP咨询洛施德GMP咨询

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Good Manufacturing Practice(GMP) data integrity: a new look at an old topic,

part 1

GMP数据完整性：老调新谈，第1部分

David Churchward, 25 June 2015 —Compliance matters

David Churchward, 2015.06.25—合规问题

Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality.

数据完整性是制药行业质量管理系统的基础，它确保药品符合质量要求。

A robust data governance approach will ensure that data is complete, consistent and accurate,irrespective of the format in which data is generated, used or retained.不论数据是以何种形式生成、使用或保留的，一个稳健的数据管理方法能确保数据的完整性、一致性和准确性。

An increased focus on data integrity and governance systems has led to serious consequences for several companies. This is the first of a series of 3 blogs which will explore elementsof organisational behavior and system design which can mean the difference between data integrity success and failure.

对数据完整性和数据管理系统的持续关注，导致一些公司产生了严重的后果。这是三个系列博客中的第一个博客，本博客将探索导致数据完整性成功和失败的组织行为和系统设计因素。

An increased focus on dataintegrity and governance systems has led to serious consequences for several companies

对数据完整性和数据管理系统的持续关注，导致一些公司产生了严重的后果。

One of the top global issues reported in the pharmaceutical media over the past 2 years has been data integrity. Regulatory actions resulting from data integrity failures have led to the withdrawal of supply across multiple markets, product recall, and serious reputational damage for those companies concerned. However this hot topic is not a new requirement, as basic data integrity principles are already described in international good manufacturing practice guidance.

过去两年里，制药行业相关媒体报道最多的全球议题之一就是数据完整性。由于数据完整性未符合相关要求而采取的监管措施导致了药品从许多市场撤销供应、药品召回以及相关制药企业蒙受巨大的声誉损失。然而，本热点话题并不是一个新的要求，因为基本的数据完整性原则早已包含在国际GMP法规中了.

There is a general misconception that data integrity failures only result from acts of deliberate fraud. Yet in the collective experience of my colleagues and me, the majority of issues relate to bad practice, poor organisational behaviour and weak systems, which create opportunities for data to be manipulated. However there is a way for companies to navigate the troubled waters of data integrity deficiencies by taking some basic behavioural, procedural and technical steps to significantly improve their systems.

只有蓄意诈骗才会导致数据完整性失败是一种常见的误区。根据我同事和我的共同经验，与不良操作、不良组织行为和薄弱系统有关的大多数问题都会为操纵数据创造机会。然而公司