沿着21 CFR第11部分生命周期的旅程

Quality Assurance Journal Pub Date : 2005-09-01 DOI:10.1002/QAJ.337

Richard M. Siconolfi

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引用次数: 1

摘要

美国食品和药物管理局(FDA)关于21联邦法规(CFR)第11部分的行业指南试图解释行业如何开发工作流程，在不损害合规性的情况下，允许该法规的灵活性。然而，为了利用这种灵活性，我们公司需要清楚地了解该指南对我们当前工作流程的影响。我们将注意力集中在两个特定领域:(1)开发和部署风险评估和管理流程，以及(2)修改计算机化系统的第11部分生命周期。版权所有©2005 John Wiley & Sons, Ltd

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A journey along the 21 CFR Part 11 Life Cycle

The Food and Drug Administration's (FDA) Guidance to Industry on 21 Code of Federal Regulations (CFR) Part 11 attempts to explain how industry can develop work processes that allow flexibility with this regulation without compromising compliance. However, to take advantage of this flexibility, our company needed to clearly understand the impact this guidance could have on our current work processes. We focused our attention on two specific areas: (1) developing and deploying a risk assessment and management process, and (2) revising our Part 11 Life Cycle for computerized systems. Copyright © 2005 John Wiley & Sons, Ltd.

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Quality Assurance Journal

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