AEVUM ZENTH
v4.2.1-RC
QC
Overall Compliance Score 99.98% ↑ 0.02% vs last quarter
Cold Chain Integrity 100% 0 Excursions (30d)
Active Audits 3 1 Pending Closeout
Training Completion 98.4% 42 Staff Pending
Non-Conformances 0 Critical: 0 / Major: 0
Serialization Rate 99.99% DSCSA / EU-FMD Ready

Compliance Matrix

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Standard / Regulation Region Category Compliance Status Last Verified Owner
Good Distribution Practice (GDP) Global / EU / UK Distribution Compliant 2024-05-14 Quality Ops EU
DSCSA Track & Trace USA SerializationCompliant 2024-05-15 ZenthTrace US
EU Falsified Medicines Directive EMA Security Compliant 2024-05-12 Security EU
WHO Good Distribution Practices WHO Distribution Compliant 2024-04-28 Global Quality
ISO 9001:2015 Quality Management ISO Management Certified 2024-01-15 ISO Lead
PIC/S GMP Guidelines PIC/S Manufacturing Compliant 2024-05-10 CMO Quality

Regulatory Standards Adherence

Temperature Mapping ✓ Valid
Valid until: 2025-02-28
All Zones (2-8°C, 15-25°C)
Validation of Packaging ✓ Valid
Valid until: 2024-12-31
Thermal & Mechanical Testing
Data Integrity (ALCOA+) ✓ Audited
Last Audit: 2024-03-15
Electronic Records Management
Supplier Qualification ⚠ Review
Due: 2024-06-01
Vendor Audit Cycle (APAC Region)

Cold Chain Zones

View All
Neo Geneva Hub (Main)
2°C — 8°C Controlled
Avg Temp:
4.2°C
Excursions:
0
Singapore DC-4
15°C — 25°C Controlled
Avg Temp:
20.1°C
Excursions:
0
Dubai Satellite-2
2°C — 8°C Controlled
Avg Temp:
6.8°C
Alerts:
1 Minor

SOPs & Policy Documents

Document ID Title Version Last Updated Owner Action
SOP-ZTH-PL-001 Cold Chain Monitoring & Alert Response v3.2 2024-04-10 Ops Dir View
SOP-ZTH-PL-014 Handling of Temperature Excursions v2.1 2024-03-22 Quality Lead View
SOP-ZTH-PL-022 Serialization & Aggregation Protocol v4.0 2024-05-01 IT Security View
POL-ZTH-SEC-009 Controlled Substance Transport Security v1.5 2024-02-15 Security Ops View