FDA Compliance - Drug Supply Chain Control Act

Effortless DSCSA Compliance and end-to-end Traceability of the drugs

Take a close look at Onelign DSCSA. See how our DSCSA solution allows you to easily trace your products while managing compliance.
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Edge Data About

Overview

FDA compliance demands fast, accurate, and transparent traceability across the food supply chain. BONbLOC’s FSMA 204–ready solution enables organizations to prove farm-to-fork traceability in hours, not days. Powered by blockchain, the platform delivers tamper-proof records, bi-directional tracing, and on-demand data access—helping businesses respond quickly to inspections, recalls, and regulatory audits while ensuring supply chain integrity and consumer safety.

We have the tools, technology and people to support rapid implementation of solution to comply with FDA requirements within the deadline.

DSCSA Requirement BONbLOC Solution Available
Exchange Exchange T3 data with all trading partners in a common platform
Interoperable Verification Data verification using GS1 or other standards
Interoperable Tracing Serialized lot tracing: one level or end-to-end
Our solution uses blockchain technology as a default data storage in order to ensure immutability and provenance.

Why choose us?

The FDA's Drug Supply Chain Security Act (DSCSA) requires stringent regulations to prevent counterfeit, contaminated, or harmful products.

Onelign DSCSA, designed to facilitate seamless compliance with DSCSA mandates for all trading partners within the pharmaceutical supply chain. By leveraging the power of blockchain, our platform enables serialized unit-level tracing of prescription drugs, thereby enhancing security and transparency throughout the entire supply chain.

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Drug Supply Chain

Benefits

Onelign Traceability offers numerous benefits to manufacturers, repackagers, wholesale distributors and dispensers. Primarily focused on enhancing transparency, security and efficiency in transaction information management within the pharmaceutical industry. Here's an overview of the benefits outlined:

Electronic Exchange

Facilitates seamless exchange of transaction information(TI) and transaction statement(TS) data between trading partners. This is achieved through secure data-sharing methods such as SFTP or AS2, ensuring secure and efficient communication.

Efficient Lot-level Tracing

Provides the ability to trace products at the lot-level, offering enhanced visibility into the supply chain. This capability enables better management of inventory and facilitates faster response in case of product recalls or quality issues.

Blockchain Platform

Utilizes blockchain technology for secure and transparent data sharing. Blockchain ensures the integrity and immutability of transaction data, enhancing trust and reliability among trading partners. It also enables interoperability through a decentralized platform.

Data Storage

Provides secure storage of transaction information, ensuring compliance with regulatory requirements. The stored data is readily available for retrieval upon request, supporting audits and investigations.

Package-level Verification

Allows verification of serialized products down to the package level. Ensures accurate tracing and authentication of individual product units.

GS1 Datahub Integration

Verifies transaction information against the GS1 Datahub for accuracy, enhancing data quality and consistency in supply chain transactions.

Receipt Verification

Validates product receipts against shipment details to enhance authenticity in transactions.

Overall, these benefits contribute to improved efficiency, security and compliance within the pharmaceutical supply chain, ultimately enhancing patient safety and regulatory adherence.

Lets Connect...

Discover the Future of Pharmaceutical Traceability with Onelign Traceability. Join us in ensuring the integrity of prescription drugs and building trust throughout the supply chain.

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