By name: "KSB-D01-K0058" description: "AI System Validation Principles: Understanding of validation principles for AI systems in pharmacovigilance including GAMP 5 AI consi..." version: "1.0.0" domain: "D01" domain_name: "Foundations of Pharmacovigilance" type: "Knowledge" proficiency_level: "L3" bloom_level: "apply" triggers: - "explain ai system validation principles" - "what is ai system validation principles" - "apply ai system validation principles" epa_mapping: "EPA-01, EPA-10" cpa_mapping: "CPA-01" regulatory_refs: ""
KSB-D01-K0058: AI System Validation Principles
Overview
Domain: D01 - Foundations of Pharmacovigilance Type: Knowledge Proficiency Level: L3 (Competent - Minimal supervision) Bloom Level: Apply
Description
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.
Context
- Major Section: AI-Era Pharmacovigilance Foundations
- Section: AI Validation Fundamentals
EPA Mapping
- EPA-01:3001-3003
- EPA-10:3023-3024
CPA Pathway
- CPA-01
Regulatory References
- General PV competency
Instructions
When this skill is activated, Claude should:
- Demonstrate L3 proficiency in ai system validation principles
- Apply apply level cognitive skills to apply the topic
- Reference relevant regulatory guidance (general PV standards)
- 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