ksb-d12-k0016

name: "KSB-D12-K0016" description: "Change Control and Validation: Change control system design and implementation, computer system validation and regulatory complianc..." version: "1.0.0" domain: "D12" domain_name: "Industry & Regulatory" type: "Knowledge" proficiency_level: "L4" bloom_level: "analyze" triggers: - "explain change control and validation" - "what is change control and validation" - "analyze change control and validation" epa_mapping: "EPA-06, EPA-09, EPA-16" cpa_mapping: "CPA-04" regulatory_refs: "FDA-CFR-004, EMA-REG-001"

KSB-D12-K0016: Change Control and Validation

Overview

Domain: D12 - Industry & Regulatory Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Analyze

Description

Change control system design and implementation, computer system validation and regulatory compliance, validation lifecycle management, risk-based validation approaches

Context

• Major Section: Global Regulatory Framework Architecture and Strategic Organizational Response
• Section: Quality Management System Architecture and Excellence

EPA Mapping

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

CPA Pathway

• CPA-04

Regulatory References

• FDA-CFR-004
• EMA-REG-001

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in change control and validation
2. Apply analyze level cognitive skills to analyze the topic
3. Reference relevant regulatory guidance (FDA-CFR-004, EMA-REG-001)
4. Connect to related EPAs: EPA-06, EPA-09, EPA-16

Key Competencies

• Change control system design and implementation, computer system validation and regulatory compliance, validation lifecycle management, risk-based validation approaches

Assessment Criteria

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

Related Skills

• Other D12 skills in Quality Management System Architecture and Excellence
• Cross-domain integrations per DAG architecture

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