Qualify Vendor

Assess and qualify a vendor providing GxP-relevant software, infrastructure, or services to ensure they meet regulatory quality standards.

When to Use

• Selecting a new vendor for a GxP-critical computerized system
• Onboarding a cloud service provider for regulated data
• Periodic re-qualification of an existing vendor is due
• A vendor audit finding requires re-assessment
• Regulatory requirement for supplier qualification (EU Annex 11 §3.4, ICH Q10)

Inputs

• Required: Vendor name, product/service, and intended GxP use
• Required: Vendor risk classification criteria
• Required: Applicable regulatory requirements
• Optional: Vendor-provided quality documentation (ISO certifications, SOC reports)
• Optional: Previous vendor audit reports or qualification records