Pharmaceutical

Regulatory-grade warehouse management for pharmaceutical distribution.FDA 21 CFR Part 11 compliance, full chain of custody traceability,and validated audit trails — without sacrificing throughput oroperational flexibility.

FDA 21 CFR Part 11EU Annex 11Chain of CustodySerialization

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WEDOFUTURE — Pharmaceutical Compliance

100%

Lot Traceability

-0

Audit Findings

GS1

Serialization Ready

// OVERVIEW

Where Every Gram is Accounted For — From Manufacturer to Patient

Pharmaceutical distribution is among the most regulated warehouseenvironments in the world. Every movement of every lot must berecorded, time-stamped, and retrievable for regulatory inspection.WEDOFUTURE delivers this level of accountability while maintainingthe throughput a hospital and pharmacy supply chain demands.

Regulatory-Grade Audit Trail

Every system action — login, task assignment, location change,quantity adjustment — is logged with user identity, timestamp,and reason code. WATCH.SCADA's alarm acknowledgments are alsofully audited for FDA 21 CFR Part 11 compliance.

DSCSA / EU FMD Serialization

Full support for drug serialization and verification under DSCSA(US) and EU FMD. Each unit is scanned at receiving, at pick,and at dispatch — creating a complete chain of custody recordfor every package in the supply chain.

Validated System Environment

STREAM.WES and WATCH.SCADA ship with complete IQ/OQ/PQvalidation documentation packages, making regulatory submissionfaster. Change control procedures are built into the software— not bolted on as an afterthought.

// COLD STORAGE

Temperature-Sensitive Pharmaceutical Handling at Every Stage

Many pharmaceutical SKUs require 2–8°C or even cryogenic coldstorage. WATCH.SCADA integrates with environmental monitoringsensors to continuously log temperature and humidity — withautomated alarm escalation if any zone exceeds its threshold.

Continuous temperature data logging at zone and equipment level
Multi-level alarm escalation if cold chain thresholds are breached
Automated deviation documentation for regulatory inspection
Integration with building management systems (BMS) for HVAC control

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WATCH.SCADA — Pharma Environmental Monitoring

// RECALL MANAGEMENT

Drug Recalls — From Notification to Affected Patients in Hours

When a manufacturer issues a recall, every hour of delay putspatients at risk. STREAM.WES supports instant lot-based searchesacross the entire distribution network — identifying exactlywhich orders contain affected product and which have alreadybeen delivered to pharmacies.

Instant lot-level traceability across all sites via CONNING.TOWER
Automated customer notification when affected lots are identified
Reverse logistics workflow for quarantine and return
Regulatory reporting templates for recall closure submissions

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STREAM.WES — Pharmaceutical Recall Control

// GET STARTED

Regulatory compliance that doesn't slow your supply chain down.

Our pharmaceutical solutions team has deep experience in validatedwarehouse environments. We'll walk you through a compliance assessmentand design a roadmap to full FDA 21 CFR Part 11 and DSCSA readiness.

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