Track & Trace

Your global partner for
end-to-end serialization

The global pharmaceutical industry faces major regulatory changes to improve supply chain security and patient safety. SCW partners with your organization to provide complete, cost-effective Track and Trace support across every major market and mandate.

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Markets covered
US DSCSA
EU FMD
Russia
Turkey
India DGFT
Brazil ANVISA
Saudi Arabia
South Korea
and more
Our approach

Complete end-to-end serialization support

With project experience across all major serialization mandates, SCW guides pharmaceutical manufacturers from initial regulatory assessment through full operational compliance, whether you are approaching a first-time implementation or managing a complex multi-market programme.

Our consultants bring hands-on expertise across L1 to L5 systems, CMO and trade partner onboarding, validation, daily operational support, and performance management, covering every layer of the serialization landscape.

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SCW Track and Trace Model
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Track & Trace service offerings

Our Track and Trace practice covers the full serialization lifecycle across 8 specialist areas, from regulatory intelligence and vendor selection through turnkey implementation, GAMP-5 validation, daily operational support, performance dashboards, training, and medical device compliance. Select a category below to explore the services within it.

Regulations

Regulations

Staying ahead of global serialization mandates is one of the most critical and time-consuming challenges for pharmaceutical companies. Our regulatory intelligence service ensures your organization always has an accurate, up-to-date view of requirements across every market you operate in, turning compliance from a reactive burden into a proactive strategic capability.

Serialization Regulation Database and Global Regulatory Requirements Updates
A single, always-current regulatory database captures global serialization mandates and timeline shifts, ensuring that regulations, timelines, and data standards remain visible and actionable. This enables proactive adjustments to artwork, data paths, and lead-time planning, shifting compliance from reactive firefighting to strategic readiness across all markets.Contact us
Vendor Selection

Vendor Selection

Selecting the right serialization technology partner is a high-stakes decision with long-term implications for compliance, cost, and operational flexibility. SCW brings structured evaluation frameworks and deep market knowledge to ensure you choose solutions that fit your business today and scale as regulations evolve, without overspending or locking you into inflexible platforms.

Serialization Landscape Evaluation
An accelerated, end-to-end diagnostic that reveals how your serialization systems, data flows, vendor integrations, and organizational practices collectively support or undermine compliance readiness. With targeted benchmarking and risk mapping, business-critical gaps are surfaced quickly so you can build a cost-effective strategy aligned with your global regulatory roadmap.Contact us
RFP: Serialization L1-5 Vendor Selections
A focused service where serialization vendors, ranging from line-level equipment (L1-L3) to enterprise software (L4-L5), are selected based on scalability, interoperability, and total cost of ownership. Capabilities are benchmarked, vendor demos are conducted, and proposals are validated to deliver clear recommendations aligned with regulatory mandates and long-term operational goals.Contact us
Implementation

Implementation

Implementation is where serialization programmes succeed or fail. SCW's implementation services span the full delivery lifecycle, from line-level integration to global partner onboarding and cross-site standardization. We coordinate every workstream from vendor integration to compliance documentation, so your serialization infrastructure is compliant, scalable, and operationally resilient from day one.

Serialization Turnkey End-to-End Implementation and Compliance
A fully managed solution spanning line-level equipment integration through L5 data exchange, designed for seamless global compliance and uninterrupted operations. From vendor coordination to operational stabilization, system validation, and compliance documentation, this service ensures serialization mandates are met efficiently across all markets.Contact us
Serialization Partner Onboarding: CMOs, 3PLs and Specialty Distributors
A structured onboarding programme built to accelerate partner readiness through centralized coordination, SOP standardization, data exchange validation, and real-time tracking tools. Clear onboarding playbooks, milestone dashboards, and hands-on support ensure consistent compliance across even the most complex global partner networks.Contact us
IT Connectivity to External Partners
A comprehensive integration service that establishes secure API connections and message-level validation between your ERP, MES, and serialization platforms and external partners. Standardized protocols, rigorous testing workflows, and governance mechanisms ensure data integrity and real-time compliance across your entire global partner network.Contact us
Aggregation Upgrades L1-5
Retrofitting lines and databases to handle not only serialized printing but also parent-child relationships and respective data transfer requirements. Often accompanied by automation such as cost-saving case packers or palletizers, these upgrades future-proof your packaging lines for evolving aggregation mandates across multiple markets.Contact us
Serialization CMO Site Readiness Checks and Visits
In-person site visits are highly beneficial for identifying the core and extended capabilities of Contract Manufacturing and Packaging Organizations. Our auditors verify equipment, processes, documentation, and data exchange at each CMO, providing documented assurance that outsourced batches will pass regulatory reviews and strengthening the long-term business relationship.Contact us
Global Serialization Standardization Programmes
Business landscapes change, such as following a merger or acquisition of an additional site. We achieve standardization by consolidating disparate processes, vendors, and code schemas into a unified global architecture. This harmonized structure unlocks operational efficiency, simplifies data governance, accelerates compliance rollout, and supports scalable serialization deployment across all markets.Contact us
Validation

Validation

Validation is a non-negotiable requirement for serialization systems in regulated pharmaceutical environments. SCW delivers rigorous, audit-ready validation documentation across every layer of your serialization architecture, from code print accuracy at L1 through to EPCIS message integrity at L5, giving regulators confidence and your operations the certainty to move at speed.

Serialization Level L1-5 Validation
Every layer of serialization is rigorously validated, from code print accuracy to EPCIS message integrity, resulting in audit-ready documentation that keeps regulators confident and shipments compliant. Quality is assured at every level, reducing risk and ensuring operational continuity from packaging line through to national repository submission.Contact us
Daily Support

Daily Serialization Support

Serialization does not stop at go-live. The real operational complexity begins once systems are live and the daily volume of alerts, data queries, and compliance events requires ongoing expert attention. SCW provides on-call serialization support that keeps your operations running smoothly and your compliance posture intact every single day, so your team can focus on throughput rather than firefighting.

Serialization Operational Support
On-call experts resolve alert spikes, rework requests, serial number verification requests, and data mismatches before they escalate into quarantine or recall events, freeing your operations team to focus on throughput rather than compliance firefighting. Available as a flexible managed service tailored to your volume and complexity.Contact us
EU FMD Alert Management and National Hub Communication
Alerts are triaged, investigated, and promptly closed at scale, ensuring national hub KPIs remain on track and product blocks are avoided. A robust hub communication process, case handling protocols, and compliance oversight keep operations smooth and customer confidence intact across all European markets, minimizing the operational and commercial impact of verification alerts.Contact us
Computerized System Validation Reports
GAMP-5-aligned validation reports confirm that computerized systems, from serialization platforms to ERP integrations, are fully fit for intended use. By delivering structured documentation against critical compliance requirements, this service satisfies inspectors while protecting patient safety and minimizing disruption to IT operations throughout system lifecycle changes.Contact us
TraceLink Release Management
TraceLink is a multi-client environment where frequent new software releases can affect daily operations. Our Release Management service evaluates each release against your specific business processes for potential impact, and where necessary, test scripts are created and provided. This documentation supports Quality teams and guarantees consistently validated computerized systems with adequate documentation at all times.Contact us
Performance Management

Performance Management

Most serialization programmes meet functional requirements but leave reporting and analytics as an afterthought. SCW bridges this gap by connecting your L1-5 systems into dynamic dashboards that give operational teams real visibility into product movement, data quality, and line-level performance, enabling root cause analysis and continuous improvement across sites and CMO networks.

Serialization Performance Management
Dynamic dashboards bridge the reporting gap by connecting your L1-5 systems, including data transfer files, to create valuable overviews of product movement, data transfer volumes, data inconsistencies, and more. This visibility enables root cause analysis and drives improvement of operational metrics on the line, across sites, and in collaboration with your CMOs, allowing for targeted and measurable improvements over time.Contact us
Training

Training

Technology is only as effective as the people using it. SCW's serialization training programmes develop competence and confidence across plant, warehouse, and quality teams, reducing human-error rejects, minimizing audit findings, and ensuring your teams can independently own compliance across the serialization landscape without relying on external support indefinitely.

Serialization Trainings and Certifications
Role-based courses develop plant, warehouse, and quality teams into confident serialization owners, reducing human-error rejects and minimizing audit findings. Practical, tailored training builds compliance readiness and operational excellence across your supply chain, empowering your teams to manage day-to-day serialization activities independently and with confidence.Contact us
TraceLink Specific Operational Trainings
Hands-on, scenario-based sessions fast-track user adoption, reduce support requests, and maximize the value gained from every new TraceLink feature, ensuring your investment delivers full ROI. Training is tailored to specific user roles and workflows, making adoption practical and immediate rather than theoretical, with measurable reductions in support ticket volume after each session.Contact us
Medical Device

Medical Device

Medical device manufacturers face their own distinct set of tracking and traceability requirements across the US and EU, governed by UDI mandates, EUDAMED registration obligations, and market-specific hub submission requirements. SCW's Medical Device practice applies the same depth of serialization expertise to the device sector, helping manufacturers navigate these mandates confidently and without disrupting commercial operations.

Medical Device US Tracking Requirements
Helping you navigate the FDA's unique device identification (UDI) mandates, ensuring your medical devices remain fully compliant, traceable, and audit-ready for the US market. We guide you through UDI labeling requirements, GUDID submission workflows, and supply chain traceability obligations, so market access is protected and inspection readiness is maintained.Contact us
Medical Device EU Tracking Requirements
Keeping you ahead of EU MDR requirements by simplifying UDI compliance, EUDAMED registration, and device traceability, safeguarding your European market access and patient safety. Our consultants ensure your systems and processes meet all submission timelines and data quality standards required by the European Medical Device Regulation.Contact us
Medical Device Tracking Implementation
Efficiently implementing robust medical device tracking solutions, aligning people, processes, and technology to enhance compliance, data accuracy, and operational efficiency. We manage the full implementation from system selection and configuration through validation and go-live, ensuring your device tracking infrastructure is ready for regulatory scrutiny from day one.Contact us
Medical Device IT Setup and Data Transmission to Respective Hubs
Secure and reliable IT infrastructure is established to enable seamless data transmission of medical device information, ensuring timely, compliant communication with global regulatory hubs. System validation, data integrity, and adherence to both US and EU reporting standards are prioritized to support ongoing regulatory readiness throughout the product lifecycle.Contact us
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