Ksb D07 K0008

• CPA-02, CPA-05

Regulatory References

• FDA-CFR-002
• ICH-E2C(R2)
• ICH-E2F
• EMA-GVP-004

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in system integration architecture
2. Apply create level cognitive skills to create the topic
3. Reference relevant regulatory guidance (FDA-CFR-002, ICH-E2C(R2), ICH-E2F, EMA-GVP-004)
4. Connect to related EPAs: EPA-02, EPA-04, EPA-05

Key Competencies

• API design, middleware solutions, real-time vs. batch processing, interoperability standards

Assessment Criteria

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

Related Skills

• Other D07 skills in Database Structure and Technical Architecture
• Cross-domain integrations per DAG architecture

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