With the expansion of serialization requirements, companies have turned to serialization technology systems to help them to manage complex specifications/regulations and to ensure compliance. However, maintaining these systems in-house can take up significant time and resources and can bring about an array of challenges, such as:
- Navigating complex serialization systems
- Monitoring an evolving regulatory landscape
- Managing ongoing support and maintenance
Leverage a managed services provider for serialization.
Outsourcing IT support equips organizations with a team that has additional in-depth knowledge of the system and allows employees to focus on other strategic initiatives. Clarkston’s serialization managed services model provides an end-to-end approach that eases the burden on your team. We have expertise in all aspects of serialization, including business processes, regulatory, systems implementations, training, and more. Since every client has their own set of serialization needs, our support model is inherently scalable. We support short-term requests, traditional skills managed services, and full outsourcing of your entire landscape.
Serialization Managed Services Consulting Solutions
Clarkston’s serialization managed services model delivers end-to-end operations support across your serialization landscape by combining system monitoring, regulatory compliance, data management, and continuous improvement to ensure business continuity. Across all of the below capabilities, we prioritize continuous improvement and knowledge management such as training materials, knowledge transfer, process optimization and automation, and service reviews. Learn more about our managed services process here.
Application and Operational Support
- 24×7 monitoring for critical serialization processes (P1/P2 incidents)
- User support, ticket triage, routing, and escalation
- Break/fix resolution and root cause analysis
- Performance monitoring and system optimization
Alert and Exception Management
- EU FMD alert monitoring, and triage (via Tracelink Alerts)
- Exception handling across EPCIS / TraceLink transactions
- Coordination with Quality (QMS/CAPA processes)
- Alert trending and continuous improvement
Trading Partner Integration
- Partner onboarding and setup (Tracelink network)
- Ongoing monitoring of partner connectivity and data exchange
- Issue resolution across CMOs, 3PLs, and wholesalers
- Vendor coordination and network performance management
Data Management & Master Data Governance
- Product, GTIN, and serial number data management
- Data quality monitoring and reconciliation
- EPCIS data issue resolution
- Ongoing data corrections and governance processes
Chance, Enhancement, and Release Management
- Configuration and functional changes within the serialization platform
- Serialization change control (aligned to GxP processes)
- Impact assessments across systems and partners
- Testing, validation, and deployment support
Regulatory Compliance and Reporting
- Monitor evolving global regulations (DSCSA, EU FMD, etc.)
- Conduct impact assessments and solution updates
- Regulatory reporting (e.g., EU Hub submissions, verification responses)
- Compliance KPI tracking and reporting
Let’s connect!
Our managed services team has worked with a variety of companies at various stages of maturity to support their live serialization system, and we continue to provide our clients with the best service possible time and time again. Leading companies engage our experts for innovative, cost-effective, and quality-focused technical solutions that deliver demonstrative value to their business. We deliver high-quality solutions with brilliant client service at a lower total cost for businesses.
- Visit our Serialization + Traceability services page.
- Learn about our AMS solutions.
- Reach out to our team today.
Contact Our Serialization Managed Services Team
Click through to contact us online or give us a call or email anytime.
Phone: (919) 484-4400
Email: info@clarkstonconsulting.com
