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Validation of Spectrometry Software Part VII - Training, System Documentation, and Writing the Validation Summary Report

机译:光谱分析软件的验证第七部分-培训,系统文档和编写验证摘要报告

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摘要

In our validation journey for a spectrometer and its software, we started with writing a system or user requirements specification, then progressed through the selection, implementation, and qualification of the system. We now come to the completion of the easy part of a system's validation: training, system documentation, and writing the validation report to release the system. In this article we'll cover the validation summary report plus three other areas that we have not discussed before: system description, system documentation, and user training with the associated procedures.
机译:在我们对光谱仪及其软件的验证过程中,我们首先编写系统或用户需求规范,然后逐步进行系统的选择,实施和鉴定。现在,我们完成了系统验证的简单部分:培训,系统文档和编写验证报告以发布系统。在本文中,我们将介绍验证摘要报告以及我们之前没有讨论过的其他三个方面:系统描述,系统文档以及相关过程的用户培训。

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