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Computer System Validation (CSV) Plan Template
High-level template for defining a structured validation approach aligned to system complexity and risk.
What This Template Provides
This computer system validation plan template provides a structured framework for planning validation activities aligned to system complexity, risk, and intended use.
It defines a high-level validation approach, including lifecycle stages, roles, and key deliverables required for validation.
Scope and Limitations
This template provides a structured validation planning framework but does not include:
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Detailed validation strategy or decision logic
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Risk assessment methodology
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Test design, protocols, or acceptance criteria
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Lifecycle control processes (e.g. change control, periodic review)
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Full system-level integration across validation activities
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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Planning validation activities for new or modified systems
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Establishing a structured validation approach
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Supporting audit readiness and regulatory expectations
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Defining validation scope for smaller or lower-risk systems
How This Template Fits into Validation
Validation planning typically forms part of a broader framework:
User Requirements
Risk Assessment
Validation Plan
Traceability
Testing / Verification
This template defines the validation planning component only and does not establish the full validation lifecycle.
→ define system intent
→ identifies areas requiring control
→ defines overall validation approach
→ links requirements, risk, and verification
→ demonstrates system performance