Pharmaceutical distribution requires validated warehouse management systems capable of meeting stringent regulatory requirements. From serialization tracking under DSCSA to controlled substance accountability, pharmaceutical WMS must provide audit trails, temperature monitoring, and compliance documentation that withstand FDA scrutiny.
Key Pharmaceutical WMS Requirements
- Serialization: DSCSA compliance with serial number capture and verification
- Lot traceability: Full forward and backward traceability for recalls
- Cold chain: Temperature monitoring and excursion management
- Controlled substances: DEA compliance and chain of custody tracking
- Validation: 21 CFR Part 11 compliant with validated processes
- Expiration management: FEFO inventory rotation and quarantine
- Electronic signatures: Secure, auditable digital approvals
- Audit trails: Complete transaction history for compliance reporting
Top Pharmaceutical WMS Vendors
- SAP EWM: Enterprise pharmaceutical distribution with validation packages
- Oracle WMS: Healthcare and life sciences industry solutions
- Blue Yonder: Pharmaceutical-specific capabilities with serialization
- TraceLink: Serialization specialist with WMS integration
Pharmaceutical WMS Considerations
- Validation approach: Vendor validation packages and IQ/OQ/PQ support
- Serialization integration: Connection to serialization platforms like TraceLink
- Temperature integration: IoT monitoring and alert management
- Regulatory updates: Ability to adapt to changing requirements
Request quotes from pharmaceutical WMS specialists with validated solutions.