Reduce the cost and complexity of complying with chain-of-custody and track-and-trace regulations including DQSA
To improve the safety and integrity of the global supply chain, government entities around the world are instituting stringent traceability regulations for pharmaceuticals and medical devices. January 1, 2015 is the first DSCSA milestone requiring manufacturers, repackagers and wholesalers to exchange lot-level TI, TH and TS for 100% of shipments.
Complying with existing regulations today while preparing for additional requirements in the future
While many organizations have already addressed existing regulatory requirements such as 21 CFR title II and Annex 11, emerging regulatory requirements in global markets will require more granular controls such as unit-level serialization, point-of-sale verification, central government reporting, and manufacturer-to-pharmacy traceability. Axway addresses these requirements with a solution that:
- Associates and manages product master, distribution channel and serialized event data
- Provides an EPCIS-compliant interface for internal and external trading partners
- Extracts and transforms data to meet country-specific reporting requirements
- Transmits compliance reports to partners or regulatory authorities with guaranteed delivery
- Leverages your investment in existing traceability infrastructure
- Establishes one global system-of-record with no data synchronization required
- Implements one centralized regulatory reporting infrastructure
- Manages one security framework with a streamlined user experience
- Maintains regional autonomy with flexible distribution center integration
Prepare for and implement DQSA Compliance with Axway Track and Trace
Axway Track and Trace helps you prepare for and implement DQSA compliance regulations by facilitating:
- Communication and information exchange with authorized trading partners to submit dispenser initial timelines and validate registration
- Exchange of transaction Information (T1), Transaction History (TH) and Transaction Statement (TS)
- Reports on suspect and illegitimate products
- Responses to requests for information
- Grandfathering products and transaction information
Axway Track & Trace has evolved from a scalable EPCIS repository to a policy-driven enterprise solution rich with features created from real-world implementations and functional specifications.
Built leveraging a SOA-based architecture combined with world-class integration technology, it provides web services APIs for serial number management, packaging hierarchy and inference support, product ID verification, and certified EPCIS capture and query interfaces.
Track & Trace provides flexible architecture options, ranging from a central global repository to a distributed network of regional repositories sharing data via EPCIS standards, and flexible deployment options, including hosted and private cloud services. Axway Track & Trace is a GS1 standards-based solution that reduces the cost and complexity of complying with chain-of-custody and track-and-trace regulations for pharmaceuticals, food products, and other manufactured goods.