洛施德GMP咨询 - MHRA BLOG GMP数据完整性：老调新谈(全集).pdf

SoltorisManagement Consultants, Inc. 洛施德企业管理咨询（上海）有限公司 Good Manufacturing Practice(GMP) data integrity: a new look at an old topic GMP 数据完整性：老调新谈 (全集，共三部分) David Churchward, 25 June 2015 David Churchward, 2015.06.25 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 an d 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 elements of 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 data integrity 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