GLP SOPs for equipment calibration and maintenance. Part 2: an organized approach to streamlining procedural documentation

M. Rosa, I. Colligon
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引用次数: 5

Abstract

As anyone who has had to deal with a Standard Operating Procedure (SOP) system can testify, managing these documents is a Herculean task, requiring full–time commitment. This article proposes an alternative and more efficient approach to building a manageable set of procedural/instructional documents that will help an organization meet its scientific and regulatory needs while alleviating the strain that a gargantuan SOP system can put on its personnel. Among the benefits of this approach are: (1) Documents are organized to follow the logical and chronological flow of the activities they describe. (2) Documents can be located quickly. (3) Users will find what they need to know, presented in a concise manner, without superfluous information. (4) Increased usability of the documents since there is a logical structure to delivered information; thus, users can control the level of detail based on their need. (5) Reduced effort for upkeep of individual documents. Copyright © 2006 John Wiley & Sons, Ltd.
设备校准和维护的GLP标准操作规程。第2部分:流程化过程文档的有组织方法
任何必须处理标准操作程序(SOP)系统的人都可以证明,管理这些文档是一项艰巨的任务,需要全职投入。本文提出了另一种更有效的方法来构建一套可管理的程序/指导性文件,这些文件将帮助组织满足其科学和监管需求,同时减轻庞大的SOP系统可能给其人员带来的压力。这种方法的好处包括:(1)文档按照它们所描述的活动的逻辑和时间顺序进行组织。(2)文件可以快速定位。(3)用户可以找到他们需要知道的,以简洁的方式呈现,没有多余的信息。(4)由于传递信息的逻辑结构,提高了文档的可用性;因此,用户可以根据自己的需要控制细节的级别。(5)减少维护单个文件的工作量。版权所有©2006约翰威利父子有限公司
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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