[COLOR=#636363]Documenting and managing clear concise and testable requirements is the cornerstone for any successful validation project. Each requirement should define clearly and precisely what the system/process/software should do and state any constraints that maybe relevant.
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[COLOR=#636363]Requirements should be reviewed and approved by the stakeholders and the subject matter experts to ensure that they meet everyone’s needs. Putting upfront effort into documenting clear unambiguous requirements will help streamline the project, reduce project risks, and of course reduce time and costs. This benefit often becomes clear later in the project where changes have the greatest impact on costs and timelines.
http://www.askaboutvalidation.com/managing-requirements-throughout-multiple-life-cycle-stages/
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