A Risk-Based Approach to Deviation Management

被引：0
|
作者：
Bredehoeft, Gail [1 ]
O'Hara, Judy [1 ]
机构：
[1] Parexel Consulting, St Lowell, MA 01851 USA
来源：
BIOPHARM INTERNATIONAL | 2009年 / 22卷 / 04期
关键词：
D O I：
暂无
中图分类号：
Q81 [生物工程学（生物技术）]; Q93 [微生物学];
学科分类号：
071005 ; 0836 ; 090102 ; 100705 ;
摘要：
A well-designed and implemented deviation management system offers a mechanism for obtaining critical quality data in a timely manner to enable quick response to failures, early warning of potential failures, and redeployment of resources to problematic areas. This article presents the key features of deviation management that can lead to early defection and resolution of problems and uncover gaps and weaknesses at a system's level that can help prevent potential problems in the future.
引用
收藏
页码：48 / +
页数：7
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