Ksb D12 K0042

• EPA-06:3013-3015
• EPA-09:3020-3022
• EPA-16:3035-3036

CPA Pathway

• CPA-04

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L3 proficiency in ai audit trail and documentation requirements
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-06, EPA-09, EPA-16

Key Competencies

• Understanding of audit trail requirements for AI-driven pharmacovigilance systems including decision logging standards, version control for models and data, change management documentation, regulatory inspection readiness, and evidence preservation for compliance demonstration. Knowledge of CIOMS WG XIV audit expectations and alignment with GxP documentation standards.

Assessment Criteria

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

Related Skills

• Other D12 skills in CIOMS WG XIV AI Governance Framework
• Cross-domain integrations per DAG architecture

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