Every saleable item will have a unique serial number (SN), and this SN needs to be captured. This is essential for fundamental supply chain processes such as order processing and receiving.
The capture can be a direct scan of a saleable product, or a scan of an aggregated product carrier from which individual unique SNs can be derived. Since this data can be in the form of 1/2D bar codes or RFID tags, realistically you must prepare to handle a combination of all three. Sophisticated multi-modal devices such as those from Motorola allow you to do this with one device.
It is not possible or practical to scan each saleable item all the time. Therefore, aggregation of serial numbers into specific carriers will be required to optimize supply chain practices.
Examples of aggregation carriers include blister packs, cases, totes, pallets and overpack containers. You should plan on these aggregated carriers being defined not only in the manufacturing setting, but all throughout the supply chain.
Serialized barcode labels on pallets, full cases and overpack containers are scanned during the shipping process to verify the accuracy of shipped items at the product or lot level against customer shipment orders. Visibility to exceptions is provided to operators in real time at the point of scanning, and the distribution centre can ship the serialized carriers without requiring operators to scan each saleable item.
In order for aggregated items to be captured and the contents assumed, there needs to be trust and accountability in the supply chain. Periodic audits to verify the aggregations should be required. A traceability audit should be available at all times.
The trust needs to validate that the aggregations are accurate, captured and labeled without error.
A trusted data source for serialization hierarchies is required. There has been much debate about who will own this data and were it will reside, but everyone agrees that this data must be maintained.
Serialization companies provide solutions that enable serialized data capture, label printing and tag management for receiving, picking, shipping, returns, deactivation, aggregation and de-aggregation of pharmaceutical products. Our solutions streamline serialization at all points in the supply chain, from manufacturers to wholesalers, distributors and retailers. Through more accurate and efficient supply chain serialization, track and trace software helps companies protect revenues, combat counterfeiting and diversion, and ensure consumer safety.
Serialization software enables “intelligent edge data capture,” allowing companies to capture and process data for serialized assets at the edge of the supply chain, where materials handling take place. By reducing data capture errors and providing real-time decision making at the point of materials handling, our solutions enable serialized product tracking without bottlenecks or bandwidth issues. Our unique distributed architecture enables agile and scalable solutions that are easily deployed and maintained to support any ERP, EPCIS / Serial Number Management, track-and-trace, Auto-ID or other application, as well as interoperability with any device for barcode and RFID data capture, using GS1 standards.
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.
Serialization Software Benefits and Features
Robust Serial Number Configuration: Basic Configuration Needs: 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, CPO’s continues to work with various standards agency and government regulators
Serial Number Allocation and Export:
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 – 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). Software 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.
Serial Number Scanning:
No Additional Hardware or Software Needed – With 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.
Auditable Data Repository:
Transaction Audits – 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. 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. CPO’s provide best-in-class pharma serialization software which quickly delivers DSCSA and FMD compliance while helping you create a smarter supply chain. Our proven track and trace software, automated implementation tools, and time-tested project management framework rapidly and efficiently ensure that you check the compliance box, but deliver so much more – a deep dive into the data and insights that drive your business forward. A real-time, detailed road map of every when and where your product has been, helps you report and improve – all in one easy-to-use, easy-to-integrate, standards-based platform.