RxChain

RxChain-Online

DSCSA SERIALIZATION SOLUTION

RxChain is an interoperable Track-n-Trace supply chain solution from LSPediA that is fully compliant with the United States’ Drug Supply Chain Security Act (DSCSA) requirements for serialization and interoperable data exchange.

rxchain

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  • Master data management
  • Complete data management with packaging
  • Complete data management with CMOs
  • Complete serialized warehouse system to pick/pack/ship aggregated shipment
  • Robust aggregation capability for stand along aggregation needs
  • High speed confirmation process to scan 2D data matrix on the outbound
  • EPCIS 1.2 data exchange with wholesale distributors

 

 

SERIAL DATA MANAGEMENT SYSTEM

Rxchain integrates with packaging lines, CMOs, Suppliers, wholesale distributors in a flexible and scale-able manner. RxChain is capable to exchange data supporting various format including EPCIS 1.0, EPCIS 1.1, EPCIS 1.2, xml, and flat files.

Integration with packaging lines

  • Generate serial numbers for packaging
  • Receive batch serial numbers
  • Receive reconciliation report

Integration with CMOs

  • Connect with CMOs via AS2, sftp, SOAP, and more
  • Issue serial numbers to CMOs
  • Receive shipment serial numbers
  • Receive reconciliation report

Connection with Suppliers

  • Connect with suppliers via AS2, sftp, SOAP, and more
  • Receive shipment serial numbers
  • Send verification request
  • Receive verification request

Meet Customer Requirement 

  • Connect with wholesale distributors via AS2, sftp, SOAP, and more
  • Send shipment serial numbers
  • Receive and respond to verification request

RxChain takes care of your DSCSA needs by managing serial numbers at the enterprise level connecting with your packaging lines, CMOs, suppliers, and customers. Coupled with its serialized warehouse management functions, RxChain ensures you are meeting with the DSCSA compliance requirement as well as enabling great operational efficiency.

 

SERIALIZED WAREHOUSE MANAGEMENT SYSTEM

Integrated with scanners, cameras, and smart devices, RxChain has robust capabilities to capture serial data through out the warehouse operations:

  • Inbound scans
  • Outbound scans
  • Verification scans
  • Reconciliation scans
  • Transaction scans

RxChain has the capability to track events by serial numbers and by transactions. It enables RxChain to associate a serial number with the purchase order, the inventory transactions, the sales order, and the RMA order, therefore enabling the end to end track-n-trace of the serialized drug product.

RxChain scans in the container SSCC number at receiving to match the EPCIS data file receive from the suppliers. This activates the supplier’s serial numbers in commercial status. RxChain scans out the 2D data matrix on the outbound associating the serial number with the sales order and records change of ownership to the seller. Returned products can re-stock by both associating to the sales order and authenticating the serial numbers.

 


 

PRODUCT FEATURES

RxChain provides the above key features to customer enabling the following serialization operation with efficiency and integrity:

  • Receiving – a built-in workflow will perform serialized quality inspection before receiving the inventory and accepting the data feed.
  • Shipping -units and cases are scanned-out and their data captured for future verification and reporting.
  • Verification – trading partner to verify serialized product at its data origin without building out an elaborate data warehouse.

key-features

 


PRODUCT VERIFICATION

RxChain enables trading partners to verify 2D labels, 2D data, and inference data with the data origin – wholesale distributors verify with labeler’s data, and dispensers verify with distributors’ data.

verification-process-flow


SECURITY & RECOVERY

RxChain is developed in the US, supported in the US, and hosted in the US data centers in a FDA Part 11 qualified environment. Security and failure recovery features are built-in to protect data integrity, data security, privacy, and business continuity:

1.       Active directory

2.       VPN connectivity

3.       Mutual authentication through certificates

4.       Federated security

5.       Data Encryption

6.       Private cloud protected against hacking

7.       Clustered VMWare with fail over, hot standby, and error recovery

8.       99.99% up time

9.       Disaster recovery with replicated dual servers in scattered US locations

10.   4-hour disaster recovery service level

 

REGULATORY COMPLIANCE

1.       Drug Supply Chain Security Act (DSCSA)

2.       FDA CFR 21 Part 11

3.       SSAE/16 Certification

4.       SOC1 and SOC2 Certifications

5.       HIPPA compliant

6.       PCI compliant

BENEFITS

It’s crucial to invest in a comprehensive solution that is scalable, configurable, and interoperable with trading partners. The RxChain embodies those qualities and bring many more benefits:

  • Lower overall serialization spending by combine EPCIS solution, warehouse solution, and verification solution in one.
  • Eliminate data errors from aggregation and data exchange with the ScanIn and ScanOut data collection coupled with unit, case, and inference real time verification with trading partner.
  • Enable serialized verification from supply chain partners by providing web mobile and desktop compatible web portal to wholesale distributors, dispensers, consumers, and regulators
  • Smart implementation and fast on boarding by utilize the built in product profile, label parsing, and partner verification network links

 

 

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