Risk-based Software Validation: Ten Easy Steps

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Risk-based Software Validation: Ten Easy Steps image
ISBN-10:

1930114982

ISBN-13:

9781930114982

Edition: 1
Released: Jan 01, 2006
Publisher: PDA/DHI
Format: Hardcover, 183 pages

Description:

This book offers a systematic, ten-step approach, from the decision to validate to the assessment of the validation outcome, for validating configurable off-the-shelf (COTS) computer software that generates data or controls information about products and processes subject to binding regulations. COTS software validation often is a time-consuming process in which a great deal of effort is spent determining the necessary validation tasks and the content and format of the validation documents. This book provides the templates and explains how to get from start to "go live" in the most time-efficient way. It is a tool to help industry professionals effectively validate the systems they need to move their businesses forward. This book comes with CD that provides with templates.

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