Our Pedigree, Trace & Track and Serialization solutions enable companies to implement and manage mass serialization of drug products and share serialized data across the supply chain, ensuring product safety and brand integrity. We have expertise in deploying market leading Trace Track and Serialization solutions including Optel™, Axway™ Trace & Track, Oracle Pedigree and Serialization Manager (OPSM).
Our Trace and Track solutions address following aspects and enable compliance with evolving track and trace authentication mandates:
- Challenges Product Counterfeiters with Globally Unique Product Unit Identification
- Supports Compliance with Global Serialization & Pedigree Regulatory Mandates
- Enables Improvements on the Bottom Line with Serialized Returns Reconciliation
- Comply with reporting and serialization requirements outlined in the U.S. Federal Drug Supply Chain Security Act (DSCSA)
- Associate and manage product master data, serialized events and distribution channel events
- Capture aggregations and change-of-ownership and de-commissioning events to provide a complete picture of the product life cycle
Our solutions are complimented with our expert professional services to enable a full solution and addressing your challenges. Our experts help you with:
- Addressing operational challenges, technologies and compliance requirements for different geographies.
- Solution accelerators that reduce implementation effort. Enable easy integration with packaging line, distribution line, SAP (Auto ID Infrastructure and Object Event Repository), and cloud infrastructure
- Solutions to manage databases, package line integration, distribution line integration, and mobile tracking
- Project management and execution
- Compliance with various regulators including FDA, EMEA, GxP, 21 CFR Part 11, Annexure 11 etc
All our early phase clinic automation services utilize our Optimized Global Service Delivery Model designed to make you fully compliant with regulatory requirements and industry standards.