State-of-the-art logistics

Pharmaceutical & Biotech

In the healthcare industry, logistics must first ensure flawless regulatory compliance: good manufacturing and distribution practices (GMP and GDP) require secure electronic records, tamper-proof audit trails and signatures that meet 21 CFR Part 11 requirements. At the same time, cold-chain management is a major challenge, and the slightest temperature excursion can wipe out the value of a batch.

The fight against counterfeiting adds an extra layer of complexity: each unit must be serialized and authenticated throughout the entire supply chain, in compliance with European directives (FMD) and U.S. DSCSA regulations. Traceability must also be near-instantaneous: a simulated recall (mock recall) must identify 100% of affected batches in less than four hours.

Faced with these multiple requirements, Fox4Work^TM stands out by integrating a compliant audit trail, real-time alerts and customized dashboards, turning the warehouse into a link that is compliant, secure and high-performing.

Your challenges

Key challenges in pharmaceutical logistics

Challenge #1

Regulatory compliance

Authorities require every logistics operation to be time-stamped, signed and stored electronically in compliance with 21 CFR Part 11 and Good Manufacturing / Distribution Practices (GMP, GDP). In practical terms, a warehouse must be able to demonstrate to inspectors that no data can be altered and that any correction leaves a readable audit trail.

Challenge #2

Cold chain

The “cold-chain” segment is growing twice as fast as ambient products: 70% of biotherapies launched over the last three years must be kept between 2°C and 8°C, sometimes starting from raw-material receiving. Any temperature excursion invalidates the batch, creates costly waste and puts reputation at risk.

Challenge #3

Serialization & counterfeiting

Since 2019 in Europe (FMD) and November 2024 in the United States (DSCSA), each box of prescription medicine must carry a unique identifier and be verified at every point in the supply chain. Returns, samples or secondary packaging flows complicate the task: serial numbers must be aggregated, disaggregated and decommissioned without error.

Challenge #4

Mock recall < 4 h

PIC/S guidelines and many AEOs require that a mock recall must trace 100% of targeted batches in less than four hours to demonstrate the effectiveness of the quality system. Without a suitable WMS, this exercise mobilizes the entire Quality team and requires manual searches through paper archives.

Strict regulatory requirements, continuous thermal control, unit-level authentication, and express recall capability represent a fourfold challenge. Ignoring any of these points risks destroyed batches, regulatory penalties, or loss of market trust.

Our industry solution “Healthcare”

Integrated audit trail, alerts, and system health KPIs.

In Fox4Work^TM, every barcode or RFID scan is time-stamped, signed, geo-located and linked to the operator. Discrepancies trigger an immediate alert; more than 50 KPIs (OTIF, dwell time, validated serialization rate, cold-chain excursions) update every second and can be filtered by Inbound, Storage, Inventory or Shipping station, by activity type or time slot.

Enhanced traceability

Fox4Work^TM can play a crucial role in the traceability of pharmaceutical products, from raw materials to finished goods. This includes batch tracking, expiration date management, and documentation of every step in the production and distribution process. Rigorous traceability is essential to ensure patient safety and to meet the strict regulatory requirements of the industry.

Optimized supply chain management

The pharmaceutical industry relies on a complex and sensitive supply chain. Fox4Work^TM helps optimize this chain by providing real-time visibility into inventory, shipments and deliveries, reducing stockouts, improving logistics efficiency and minimizing risks related to counterfeiting or defective products.

Simplified regulatory compliance

The pharmaceutical sector is one of the most highly regulated in the world. Fox4Work^TM can be a major asset in ensuring compliance with international standards (such as GMP – Good Manufacturing Practices) and local regulations. Through document management, audit, and reporting features, the platform helps companies maintain accurate records and demonstrate compliance during inspections.

Improved operational efficiency and cost reduction

By automating key processes and providing better data management, Fox4work^TM can contribute to a significant improvement in operational efficiency. This can result in a reduction of manual errors, faster production and distribution cycles, and, ultimately, a decrease in costs related to operations, product returns, or non-compliance penalties.

GMP requirements, critical cold chain, unit-level serialization: pharma logistics is a tightly controlled journey. Fox4Work^TM secures every link, proves compliance in one click and delivers tangible financial and operational gains—a competitive advantage for any healthcare/biotech player.

Our clients

Pharmaceutical sector

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Learn more

The 4 key challenges a WMS must address

Whether it is an e-commerce hub or an industrial platform, four challenges now dominate logistical performance: maintaining a reliable inventory to avoid stockouts and overstocking, accelerating order picking—which absorbs up to 70% of warehouse labor—smoothing out receiving and shipping to reduce truck dwell time (frequently exceeding two hours), and guaranteeing exhaustive traceability capable of reaching 99% accuracy through the barcode/RFID pairing.

A WMS like Fox4Work tackles these four areas head-on: real-time visibility for every SKU, dynamic slotting and batch picking to eliminate unnecessary travel, dock scheduling and directed put-away to relieve docks, and time-stamped audit logs with live KPIs to move from annual inventories to continuous control.

Discover how Fox4Work addresses each of these challenges—and why mastering them determines a warehouse’s profitability.

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