Excel电子表格规范的实用方法(中英文对照)
A Pragmatic Approach to the Specification of Excel Spreadsheets
Excel 电子表格规范的实用方法
GxP critical spreadsheets need to undergo specification to ensure that the user’s needs
and the spreadsheet’s functionality is clearly defined and documented. This paper
describes a pragmatic approach to the specification of Excel spreadsheets using a single
generic document. The approach described is easily transferred to other simple systems
such as databases and standalone instrumentation.
GxP 关键的电子表格需要进行规范以保证用户需求和电子表格功能可以清晰地定义和记录，
本文叙述了使用单个通用性的文件来规范Excel 电子表格的实用方法。该方法也可以简单的
运用到其他简单的系统比如数据库和独立仪器。
By Da vid Harrison & David A Howard
Key Words: Validation, Compliance, Spreadsheets, MS Excel, 21 CFR Part 11,
Pharmaceutical, GAMP, GxP, GLP, GMP, GCP, End User Computing, Specification
Introduction
This continues the series of short articles describing a generic process for validating Excel
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Spreadsheets. A previous article gave an overview to the process, whilst a subsequent
topic will cover the testing and qualification.
简介
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本文通过一系列的短篇文章来叙述Excel 电子表格验证的一般程序。先前的一篇文章 已经
对这个程序进行了概述，随后的主题将包含这些测试和确认。
Although this article specifically covers Excel, the principles can be adapted to cover a
wide variety of applications. This process has been successfully used on Access
Databases, and other straightforward applications such as standalone instrumentation
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and off the shelf software packages . The focus is on minimising the document set, and
providing all relevant information in a single generic specification with all critical items
covered.
尽管本文特别涵盖了Excel，但其中的原则可适用于更为宽泛的应用。这套程序已经成功的
运用于Access Databases， 其他简单的应用比如独立仪器和现成的软件包。本文关注
