ksb-d01-k0058

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:

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

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