Trace User Need to Validation
Build a basic trace from user need to validation evidence.
An alarm feature has a verified tone but no evidence that intended users notice and act on it in a realistic environment. Design-control traceability connects user need to design input, design output, verification, and validation so the file proves both specification conformance and intended-use fit. The common shortcut is treating a passed bench test as validation even when the test never represented the user, use environment, or clinical action. State the user need Nurses need to detect and respond to occlusion alarms during normal ward noise and competing tasks. This is about the user's job, not the component specification. Translate…
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