The challenges of product serialization for pharmaceutical and medical device companies are significant. With the new requirements for tracking pharmaceutical products individually throughout the supply chain, trading partners are increasingly demanding shipment aggregation. Globally, particularly in the US, Europe, and Asia, traceability standards are becoming stricter.
The main challenge for companies is to manage this transition successfully while minimizing business disruption. Many current serialization systems are a legacy system, so companies need an implementation strategy that meets new requirements, overcomes operational challenges, and offers benefits beyond compliance.
Level 3 Systems: These systems which is often hosted outside the company firewall or in the cloud connect with multiple Level 2 systems at each site and Level 4 software. Typically, there is one Level 3 system per packaging facility. Level 3 systems manage serialization workflows at the packaging line level, handling work orders, serial number workflows between Level 4 and packaging lines, master data, and exchanging serialized data with Level 4. However, they often lack verification and validation of the data, requiring manual checks for serialization, aggregation, and shipment accuracy.
THE CURRENT SCENARIO
Despite efforts to automate serialization, manual interventions are still needed to reduce errors and disruptions in the supply chain. This is a common practice among many manufacturers and CMOs, though it may not apply to all companies;
- Serialization: Request, Review and Confirmation Process.
- Batch / Lot: Request, Review and Confirmation Process.
- Shipment: Request, Review and Confirmation Process.
Processing serialized shipment: may not cover the entire spectrum of validation & verification
#Exceptions that may occur:
- Transmission Exceptions
- serial number configuration
- file structure format (EPCIS, XML)
- data element format
- event sequencing and chronology
- late transmissions (AS2 setup)
- missing data elements/master data
- Aggregation Exceptions
- aggregation mismatch – Item to case
- serial number error – disposition, invalid SN etc.
- data mismatch;
- lot and exp date does not match SN
- scanned lot does not match with EPCIS data
- scanned expiry does not match with EPCIS data
- Some of the exceptional demands from MAH to CMOs
- sending back unused SN (as decommissioned)
- include PO number in shipment file
- include delivery number in shipment file
- multiple ship to location
- moving ship to location: logistic workflow must be reflected in data transfer
From workflow perspective the challenges could be;
- Validation: The data exchange between L3 system and L4 system is asynchronous.
- Verification: Since the communication is async, manually verify the batch and its details in L4 system.
- Orchestration: Further manually trigger the shipping event in L4 system
THE PRESSING NEED
A system/application that ensures smooth interoperability among all machines, devices, business systems, and databases involved in the pharmaceutical supply chain.
Data Validation: Responsible for data validation to and from L4 system, ensuring adherence to predefined standards and formats.
Data Verification: Conducts verification checks on serialized data, ensuring compliance with L4 system and other system-specific requirements.
Data Orchestration: Manages the flow of data between L3 and L4 systems, coordinating serialization tasks in a seamless manner.
Error Handling: Handles error detection, logging, and reporting to ensure the system’s integrity and reliability.
In summary, this system is essential for efficient, accurate, and secure pharmaceutical serialized shipments, providing seamless integration, real-time monitoring, and automation. This system should be able to facilitate the verification, validation and circulation of serialized data between level 3 and level 4 systems;
- Transfer DA/DU from L3 to L4
- Acknowledge DA/DU receipt in L4
- Cross-check batch quantity between L3 & L4
- Send trigger for shipment notification to L3
- Transfer sales shipment from L3 to L4
- Acknowledge shipment event transaction sent to customer from L4
- Notification to QA of successful processing, basis which QA to certify the batch
Additional feature to further enhance ‘zero’ error shipment file processing;
Query Initial DA File to Understand Hierarchical Data in Any Batch
The system should enable better understanding and transparency of data between L4 and L3 after posting the Disposition/Commission file allowing the CMO customer to check the Lot status, Expiry date, Aggregation hierarchy, Quantity, Product Master data, etc., CMO should be able to verify this first before releasing the file. This will help avoid errors at Level 4 and provide better visibility for various user-level checks.
Option to Perform Transformation Event for Any DA File via User Interface or File Upload
The system should allow for generating a Commission Updates and send it Level 4 when the L3 doesn’t have the capability to send the updated file to Level 4, thereby reducing errors in Level 4 for exceptional use cases.
How can CosmoTrace Help?
CosmoTrace plays a crucial role in facilitating the pharmaceutical serialized shipment process by acting as a bridge between different systems, ensuring data integrity, and streamlining various functions.
Please write to us on jaweed@cosmotrace.com for more details.