Enterprise-Grade Pharmaceutical Traceability

GS1-compliant unit-to-pallet tracking with zero consumer data capture.

  • ✔ GS1 QR & DataMatrix only
  • ✔ Unit → Box → Carton → Pallet (SSCC)
  • ✔ Code-only security model

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Regulatory Compliance Overview

RxTrace supports GS1-aligned serialization and traceability workflows required under major global and Indian pharmaceutical regulations.

EU-FMD

Mandatory GS1 DataMatrix with unique identifier for prescription medicines across the European Union.

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US-FDA (DSCSA)

Serialized product identifiers required for interoperable electronic tracing of prescription drugs.

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Indian FDA

QR / barcode mandate for top drug formulations under amended Drugs & Cosmetics Rules.

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CDSCO

GS1-based identification and traceability aligned with India’s central drug regulator guidelines.

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How RxTrace Works

A simple GS1 compliant traceability process from company setup to label generation and printing.

Step 1

Setup Company

Register company details and compliance profile once in the system.

Step 2

Create or Upload Product

Create product manually or upload CSV with SKU, batch, MFD, MRP, expiry date and optional GTIN.

Step 3

Save Product & SKU

Product and SKU data is validated and saved for traceability use.

Step 4

Setup Printer

Configure printer or output format such as PDF, PNG, EPL, or ZPL.

Step 5

Set Packaging Rules

Define box, carton and pallet hierarchy using SSCC rules.

Step 6

Generate GS1 Payload

GS1 compliant payload is generated with serialized product data.

Step 7

Add to Batch

Generated payloads are grouped into batches for controlled processing.

Step 8

Generate & Print Codes

Export labels in PDF, PNG, EPL, ZPL format or print directly.

Industry Support

RxTrace is designed to support all key participants in the regulated supply chain with a single GS1 compliant traceability system.

Manufacturers

  • Generate GS1 QR or DataMatrix codes
  • Serialize products at unit level
  • Meet India, US, and EU regulations
  • Prepare audit ready reports

Distributors

  • Verify incoming and outgoing shipments
  • Scan cartons and pallets using SSCC
  • Handle partial shipments easily
  • No access to manufacturer sensitive data

Warehouses

  • Quick receiving and dispatch scanning
  • Pallet and carton level visibility
  • Support cold chain and 3PL operations
  • Reduce manual inventory errors

Logistics

  • Track movement without data duplication
  • Scan once, use everywhere
  • Compatible with existing workflows
  • Improved traceability across transit

Data Security and Trust

RxTrace follows a code centric security model that minimizes data exposure while meeting regulatory traceability requirements.

Code Only Architecture

  • All trust is embedded inside GS1 codes
  • No dependency on personal data
  • Works even without internet access

No Consumer Data Capture

  • No patient or consumer tracking
  • No scan level personal data stored
  • Privacy safe by design

Controlled Access

  • Role based user permissions
  • Token based handset activation
  • Higher scans enabled only when authorized

Audit Ready

  • Immutable generation logs
  • Packaging and aggregation history
  • Regulator friendly reports