Kiss CSV Services
Keeping Compliance
Simple & Straightforward
Traceability Matrix Template (TM)
Template for establishing structured traceability between requirements, risk, and verification activities.
What This Template Provides
This template establishes traceability between user requirements, associated risks, and verification activities.
It provides a structured approach to demonstrating alignment between system intent and validation outcomes.
Scope and Limitations
This template provides a structured traceability framework but does not include:
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Risk assessment methodology
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Traceability logic or mapping rules
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Test design or protocol development
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System categorisation or impact assessment
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Full validation lifecycle integration
These elements should be further developed where required to support a level of control appropriate to system complexity, risk, and regulatory expectations.
What’s Included
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Traceability matrix structure (requirements, risk, testing)
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Example entries demonstrating linkage
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Requirement-to-risk reference framework
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Verification reference structure
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Format aligned to validation expectations
When to Use This Template
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Linking requirements to validation activities
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Supporting audit readiness and traceability expectations
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Demonstrating alignment between system use and verification
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Structuring validation documentation for smaller or lower-risk systems
How This Template Fits into Validation
Traceability is typically established as part of a broader validation framework:
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User Requirements
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Risk Assessment
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Traceability
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Testing / Verification
This template provides the traceability component only and does not define the full validation process.
→ define system intent
→ identifies areas requiring control
→ links requirements, risk, and verification
→ demonstrates system performance