Perform CSV Assessment

Conduct a Computer Systems Validation assessment using GAMP 5 risk-based methodology for regulated environments.

When to Use

• A new computerized system is being introduced in a GxP environment
• An existing validated system is undergoing significant change
• Periodic revalidation is required
• Regulatory inspection preparation demands a validation gap analysis

Inputs

• Required: System description (name, purpose, vendor, version)
• Required: Intended use statement and regulatory context (GxP scope)
• Required: GAMP 5 software category (1–5)
• Optional: Existing user requirements specification (URS)
• Optional: Vendor documentation (design specs, release notes, SOPs)
• Optional: Previous validation documentation