Onelign Traceability
FDA's Drug Supply Chain Security Act (DSCSA) mandates an electronic tracing system for drugs at the package level to ensure the verification of legitimacy of the drugs throughout the distribution process.
Problem
Statement
FDA's Drug Supply Chain Security Act (DSCSA) mandates an electronic tracing system for drugs at the package level to ensure the verification of legitimacy of the drugs throughout the distribution process.
Counterfeit Drugs Threat
Counterfeit drugs pose a significant risk to public health. Enhancing mechanisms to detect and prevent the circulation of fraudulent pharmaceuticals is critical to maintaining the integrity of the drug supply chain.
Data Sharing Challenges
Effective collaboration and data exchange among trading partners are essential for DSCSA compliance. Issues related to data sharing and interoperability hinder seamless information flow, impacting traceability and transparency. Improving data-sharing mechanisms is vital for overall compliance.
DSCSA Requirements Across the Supply Chain
01
All entities are required to authenticate drug products by confirming serialized identifiers against the TI and TS information shared by their trading partners.
02
Manufacturers must assign unique product identifiers or serial numbers to each package, ensure secure transfer of products through authorized trading partners.
03
Third-party logistics providers will need to upgrade their systems to manage serialized products and support the secure exchange of drug tracing information.
04
Pharmacies and Hospitals must be prepared to receive and process serialized drug packages and integrate product tracing information into their dispensing operations.
All the members in the supply chain should notify the US Food and Drug Administration of any illegitimate drugs they come across. The DSCSA Stabilization Period requires full compliance by November 27th, 2024.
Solution
Proposed
ONELIGN DSCSA offers seamless compliance with the Drug Supply Chain Security Act (DSCSA), ensuring end-to-end traceability of drugs. Leveraging blockchain technology, ONELIGN provides secure and transparent data sharing, thereby safeguarding the integrity of transaction data. The DSCSA Compliance solution ensures the fastest time to compliance and is cost-effective.
Business
Value
01
Enabling electronic exchange of required TI and TS data between trading partners
02
Validating package identifier (PI) to identify the prescription pharmaceutical product at package level.
03
Verifying the product identifier on a package or sealed case by trading partners.
04
Enabling trading partners to provide TI and TS when requested by authorized agents.
05
Ensuring that each event (TI) is traced to the manufacturer or between partners (custody information).
06
Retention of transaction data for a minimum period of 6 years, available for retrieval on demand.
07
Quick integration with existing ERP, PO, Inventory or WMS applications.
08
Exception and error handling support through automated alerts and managed follow-up services.
09
Easy and intuitive user interface/experience backed up by award-winning managed services support.
Overall, the Onelign DSCSA Solution significantly contributes to a more secure, transparent, and compliant pharmaceutical drug supply chain. It helps maintain the integrity of the drug products from manufacturer to end-consumer.