Serialize with the industry’s most advanced serialization software.
Governments around the world are defining new initiatives and enacting laws to reduce the proliferation of counterfeit drugs. Using serialization as a foundational requirement, governments are enacting electronic systems to identify and trace prescription drugs as they are manufactured and distributed. Depending on the government, these regulatory requirements will apply to manufacturers, re-packagers, wholesale distributors, dispensers and third-party logistics providers. With serialization software, products are assigned a unique serial number to each saleable unit of each prescription product. The serial number is linked to information about the product’s origin, batch number and expiration date. The units can then be tracked through its entire supply chain - from manufacturing to distribution and the final dispensation to the patient. rfxcel has partnered with the pharmaceutical industry to meet this challenge. As the pioneer in this space, rfxcel offers the most robust and flexible serialization software in the industry. Our commitment to industry standards ensures that our customers can work seamlessly with all trading partners in their supply chain. Additionally, our integration technology allows communications with partners who have specialized integration requirements.Serialization Software Benefits and Features: Robust Serial Number Configuration:
- Basic Configuration Needs: rfxcel Serialization Software can generate serial number formats to meet all regulatory requirements. Common features such a numeric, alpha-numeric, sequential and random numbers are easily support.
- Unique Configuration Needs: More complex features such hexadecimal or Brazil’s random probability is also supported. rfxcel continues to work with various standards agency and government regulators to ensure that rfxcel Serialization Software continue to meet any upcoming serialization requirements.
- Who Must Export – MAH (Market Authorization Holder) organizations will, in most cases, want full control of how serial numbers are generated and who they are be allocated to. This is true for both manufacturers with in-house line systems and virtual manufacturers who outsource the manufacturing.
- Managing Allocations/Exports – rfxcel Serialization Software not only verifies who should receive serial numbers but our platform also controls how the serial numbers are allocated to line systems and CMO/CPO’s. Restrict allocation by a range, maximum limit per request, total serial numbers on-hand as well as many other features.
- Data Verification – Allocated/Exported serial numbers must eventually be processed and reported back to the MAH holder (who then must report to regulatory agencies). rfxcel’s solution provides extensive data verification checks to ensure the quality of the data. Examples include: checking for duplicates; confirming the format and packing levels; verifying that only previously allocated numbers are received.
- Who Must Import – Contract Manufacturing and Packing Organizations (CMO/CPO) are often required to import serial numbers from the MAH (Market Authorization Holder) organization. In some cases, even MAH organizations are required by governmental regulatory agencies (e.g. China) to import serial numbers from a centralized government site.
- The Challenge of Importing – Currently, there are not industry standards regarding the interface or protocols for importing serial numbers. This is defined by the organization responsible for generating serial numbers and must be adhered to by the requesting organization.
- Architected to Simplify Importing – rfxcel Serialization Software has been architected so that requesting organization can easily integrate with MAH organizations without the need for a full revalidation of the solution.
- Large Partner Ecosystem – rfxcel supports a large number of supply chain partners who are already integrated with our solution. In many cases the importation interfaces with your specific MAH holder is already in place and ready for use.
- No Additional Hardware or Software Needed – with rfxcel Serialization Software, customers are not required to buy additional hardware or software. Customers just need to plug in a PC compatible scanner and start scanning serial numbers. It is that simple.
- Dynamic Recognition – rfxcel Serialization Software dynamically recognizes and pulls in the relevant data from the GS1 barcode into the system. The system automatically recognizes the product type (product, case or pallet).
- Transaction Audits – rfxcel Serialization Software captures and stores all serialization data sent from the site level systems. Full transaction history of all serialized items and events are maintained. This includes not only receipt of data but any voiding or reprocessing of events.
- Master Data Audits – Any change to master data is fully audited with before/after information, as well as time and user ID.
rfxcel is committed to supporting industry standards. Our software is designed according to the internationally accepted ANSI/ISA S95 standard. This enables an efficient solution that integrates with external packaging equipment, line controllers, and central repositories via standard interfaces for seamless communication. This architecture ensures seamless information exchange with all partners in the supply chain. From its early beginning, rfxcel’s Supply Chain & Traceability Software was developed with a core design principle for information flow; “No Garbage In means No Garbage Out”. rfxcel continuously monitors incoming data to ensure data quality. This focus on the quality of the data entering into our solution minimizes issues when reporting to downstream partners and agencies. Our software is deployed to customers via a private cloud that is dedicated to that individual customer. This provides our customers with full control of their environment. Customer software instances are not automatically updated without a customer’s approval. There is no forced upgrade. The customer can determine what upgrades to accept, and when these upgrades should be applied. rfxcel's private cloud approach allows customers to validate and test their upgrades in accordance with the customer’s quality standards. rfxcel is here to provide the industry the solution that best fits their needs and requirements. For more information and a 30-minute demo please contact us.