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Life Sciences: Pharmaceuticals & Medical Devices

Secure your supply chain with the industry’s longest-tenured track and trace solutions.

Popular Features

  • Raw ingredients to finished goods traceability
  • Real-time cold chain monitoring
  • Compliance management
  • Predictive analytics

Learn more about rfxcel products

GLOBAL COMPLIANCE REQUIREMENTS

The industry’s most comprehensive compliance reporting solutions.

Serialization. Traceability. Compliance.

rfxcel is committed to improving patient health and safety, combatting counterfeit drugs, and securing supply chains. Our compliance solutions report into all global government agencies, so you will be compliant no matter where you do business.

  • United States
  • Europe
  • Russia
  • Brazil
  • India
  • Saudi Arabia

UNITED STATES: FDA DRUG SUPPLY CHAIN SECURITY ACT (DSCSA)

The DSCSA compliance laws aim to facilitate the exchange of information at the individual package level about where a drug has been in the supply chain to:

  • Enable verification of the legitimacy of the drug product identifier down to the package level
  • Enhance detection and notification of counterfeit products in the drug supply chain
  • Facilitate more efficient recalls of drug products

 

What manufacturers must do

  • Lot-level management: Share “the 3Ts”: Transaction Information (TI), History (TH), and Statements (TS) at the lot (or batch) level of identification
  • Item serialization (2017–2019): Serialize packages of drug products using a product identifier (GTIN or National Drug Code), serial number, lot number, and expiration date
  • Serialized item-level traceability: By November 2023, make available information that will allow supply chain partners to trace ownership back to the initial manufacturer or repackager.

rfxcel products

rfxcel Traceability System (rTS) with Serialization Processing and Compliance Management 

 

What repackagers must do

  • Lot-level management: Share the 3Ts
  • Item serialization (2017–2019): Serialize packages of drug products using a product identifier (GTIN or National Drug Code), serial number, lot number, and expiration date

rfxcel products

rfxcel Traceability System (rTS) with Serialization Processing and Compliance Management

 

What wholesale distributors must do

  • Lot-level management: Share the 3Ts
  • Verify every product’s serial number
  • Must receive verified serial numbers from manufacturers

rfxcel products

rfxcel Verification Router Services (rVRS)

 

What dispensers (e.g., hospitals, pharmacies, clinics) must do

  • Lot-level management: share the 3Ts (to be prepared for audits)

rfxcel products

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