Serialization & Supply Chain
Compliance Services
Our Serialization Services
Ensuring compliance with global drug traceability regulations, such as the U.S. DSCSA (Drug Supply Chain Security Act) and the EU FMD (European Falsified Medicines Directive), is critical for pharmaceutical companies. At VariTec Consulting, we offer comprehensive serialization program management customized to meet your specific regulatory needs, helping you navigate complex compliance landscapes and implement serialization solutions that enhance supply chain transparency, security, and integrity.
Our team partners with you from day one to develop and implement an optimal serialization strategy tailored to your operations. Whether preparing for DSCSA, EU FMD, or other global traceability standards, we ensure your serialization program meets current regulatory requirements, providing peace of mind that your supply chain remains fully compliant.
Partner Onboarding & Readiness
Serialization requires not just internal readiness but also close collaboration with your external partners, including contract manufacturers, wholesalers, and logistics providers. VariTec’s Onboard Partner Program ensures that we evaluate each of your business partners’ readiness and willingness to comply with regulatory requirements, performing thorough risk assessments to minimize disruptions in your supply chain.
L4/L5 System Integration & Validation
Our L4 System Validation services provide flexible solutions for testing, validating, and producing serialization data at the enterprise level. From ensuring proper data flow between line-level (L2/L3) systems to your central repository (L4/L5), our validation services cover every aspect of the process, ensuring compliance and operational continuity. We also empower you to maintain control over system updates, ensuring flexibility and scalability as your needs evolve.
Alert Management & Operational Support
Serialization doesn’t stop with implementation—it’s a continuous process. Our expert team offers Alert Management, Analysis, and Resolution services to ensure that serialization data is accurately reported and any issues are promptly addressed. From alerts generated during production to compliance reporting, we help you stay ahead of any potential disruptions in your serialization operations.
Data & Analytic Services
Data is at the heart of serialization and traceability. Our Data & Analytic Services leverage advanced analytics and digital transformation tools to turn your serialization data into actionable insights. From supply chain optimization to regulatory compliance tracking, we support you throughout your Data Transformation journey—from defining a data strategy to setting up Data Platforms as a Service (DPaaS).
Global Compliance Focus: DSCSA & EU FMD
DSCSA Compliance
(U.S.)
The Drug Supply Chain Security Act (DSCSA) mandates a secure and interoperable system for tracking prescription drugs through the U.S. supply chain. By 2024, full serialization, verification, and traceability will be required. VariTec Consulting ensures you’re fully prepared with:
- Serialized product tracking from manufacturer to dispenser.
- Data integration with trading partners.
- Compliance with Interoperable Electronic Systems for transaction data.
EU FMD Compliance
(European Union)
The European Falsified Medicines Directive (FMD) mandates the serialization of prescription medicines and the application of anti-tampering devices. We assist in:
- Implementing 2D barcodes and unique identifiers for product authentication.
- Integration with the European Medicines Verification System (EMVS).
- Ensuring end-to-end traceability across all stages of production and distribution.
DSCSA Compliance (U.S.)
The Drug Supply Chain Security Act (DSCSA) mandates a secure and interoperable system for tracking prescription drugs through the U.S. supply chain. By 2024, full serialization, verification, and traceability will be required. VariTec Consulting ensures you’re fully prepared with:
- Serialized product tracking from manufacturer to dispenser.
- Data integration with trading partners.
- Compliance with Interoperable Electronic Systems for transaction data.
EU FMD Compliance (European Union)
The European Falsified Medicines Directive (FMD) mandates the serialization of prescription medicines and the application of anti-tampering devices. We assist in:
- Implementing 2D barcodes and unique identifiers for product authentication.
- Integration with the European Medicines Verification System (EMVS).
- Ensuring end-to-end traceability across all stages of production and distribution.
Expertise with Top Serialization Platforms
Our team of experts is well-versed in leading serialization applications, providing unparalleled expertise in the implementation and management of the following platforms:
LSPedia
Comprehensive track-and-trace solutions with a focus on DSCSA compliance and data management.
SAP ATTP (Advanced Track and Trace for Pharmaceuticals)
Industry-leading software for serialization and regulatory compliance.
SAP ICH (Information Collaboration Hub)
A cloud-based solution to manage serialization data exchange with trading partners.
Rfxcel
Serialization and traceability solutions for the pharmaceutical industry, enabling compliance with DSCSA and EU FMD.
Axway
Secure data integration and real-time exchange across your entire supply chain.
Additional Services
Big Data & Data Modernization
Before migrating your serialization data to the cloud, we guide you through the essential phases:
- Discovery Phase: Document your current infrastructure and define your business goals.
- Planning Phase: Develop a detailed cloud design and migration strategy.
- Evaluation Phase: Build the business case for migration, ensuring cost and risk assessments are in place.
Master Data Management (MDM)
Effective Master Data Management is critical to serialization. We help align your people, processes, and technologies to maintain high data quality and governance standards, ensuring reliable serialization data across all systems.
Data Operations (DataOps)
DataOps bridges the gap between data engineering, analytics, and business users. Our DataOps approach fosters innovation by delivering high-quality, rapid-response data analytics, critical for ensuring the smooth operation of your serialization program.
Resources & Expertise
At VariTec Consulting, our team of experts is ready to support you through every phase of your serialization journey. Whether you need Senior Subject Matter Experts, Technical Consultants, or Data Engineers, our in-house team is available to provide the specialized skills required to meet your business goals.
Validation Specialists
Program & Project Managers
Business
Analysts
We ensure that your serialization program is in expert hands, from system validation and regulatory compliance to alert management and data analytics.
Explore Our Case Studies
We’ve successfully transformed IT environments for businesses across various industries. Visit our Case Studies section to see how VariTec has solved IT challenges and delivered meaningful outcomes for companies like yours.
Get Started with VariTec Consulting
Contact Us today to learn how we can help your business achieve full serialization compliance and streamline your global supply chain operations.