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kak33 replied to the topic Customer Needs, Business Requirements, Test Plan in the forum Introduction to Design Controls 7 years, 5 months ago
At my company, we document user requirements in its own document. The user requirements also drive design input requirement and are linked via a trace. When an input requirement is changed or modified, we also evaluate potential impact to the user requirements or if re-verification is required. Similar to the design inputs the user requirements are specific but a little more high level, like a a wish or a feature.