Ksb D01 K0058

• CPA-01

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L3 proficiency in ai system validation principles
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-01, EPA-10

Key Competencies

• Understanding of validation principles for AI systems in pharmacovigilance including GAMP 5 AI considerations, CSV lifecycle for ML models, validation documentation requirements, and ongoing validation for adaptive AI systems.

Assessment Criteria

• Can apply core concepts independently
• Demonstrates understanding of regulatory context
• Applies knowledge appropriately to PV scenarios

Related Skills

• Other D01 skills in AI Validation Fundamentals
• Cross-domain integrations per DAG architecture

Generated from PV KSB Framework v1.0 | 2025-12-31