| name | KSB-D12-K0042 |
| description | AI Audit Trail and Documentation Requirements: Understanding of audit trail requirements for AI-driven pharmacovigilance systems including decision... |
| version | 1.0.0 |
| domain | D12 |
| domain_name | Industry & Regulatory |
| type | Knowledge |
| proficiency_level | L3 |
| bloom_level | apply |
| triggers | ["explain ai audit trail and documentation requirements","what is ai audit trail and documentation requirements","apply ai audit trail and documentation requirements"] |
| epa_mapping | EPA-06, EPA-09, EPA-16 |
| cpa_mapping | CPA-04 |
| regulatory_refs | |
KSB-D12-K0042: AI Audit Trail and Documentation Requirements
Overview
Domain: D12 - Industry & Regulatory
Type: Knowledge
Proficiency Level: L3 (Competent - Minimal supervision)
Bloom Level: Apply
Description
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.
Context
- Major Section: AI Governance and Regulatory Compliance
- Section: CIOMS WG XIV AI Governance Framework
EPA Mapping
- EPA-06:3013-3015
- EPA-09:3020-3022
- EPA-16:3035-3036
CPA Pathway
Regulatory References
Instructions
When this skill is activated, Claude should:
- Demonstrate L3 proficiency in ai audit trail and documentation requirements
- Apply apply level cognitive skills to apply the topic
- Reference relevant regulatory guidance (general PV standards)
- 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
