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Serialization & Track-and-Trace: Page 59
Robotics/Automation
Line- and plant-level software implications
While GS1’s Electronic Product Code Information Services (EPCIS) protocol standardizes the way serialization data is transmitted between trading partners, there is no such standard for communicating between a company’s internal serialization solution and its Manufacturing Execution System (MES), Enterprise Resource Planning (ERP) systems such as SAP, and ERP modules that handle serial number management (such as Aii in the case of SAP). And therein lies the rub.
January 8, 2014
Pharmaceuticals
Preventing counterfeit e-pedigree data
Although many people may think of serialization and e-pedigree as the industry’s final checkmate in the counterfeit arms race, nothing could be further from the truth.
January 7, 2014
Robotics/Automation
How to avoid the leading zero issue
There are a number of layers of software systems involved in serialization: line- and plant-level serialization systems, ERP-level serial number management systems, and network-facing EPCIS systems.
January 7, 2014
Pharmaceuticals
Impact on wholesaler/distributors, pharmacies, clinics, and hospitals
Wholesaler/distributors face an incredible challenge. They will receive data from hundreds of suppliers—and must disseminate it to thousands or tens of thousands of customers—and have to figure out how to manage it all.
January 6, 2014
Materials
E-pedigree models and the U.S. drug supply chain
The debate over pedigree regulatory models in the U.S. pharmaceutical supply chain often centers on how much data for each package of drugs needs to be moved between trading partners as those drugs physically move through the supply chain.
January 6, 2014
Pharmaceuticals
Impact on production/operations workflows
Pharmaceutical companies are finding that the cost to upgrade a typical packaging line for serialization runs at around $1 million, give or take. With that level of investment, it’s only natural to focus on the equipment and engineering changes involved in reconfiguring the line itself.
January 5, 2014
Pharmaceuticals
Questions to ask your CMO/CPO about serialization
While the focus of many pharmaceutical manufacturers is on their own internal infrastructure, it’s prudent for manufacturers to begin surveying their contract manufacturing and contract packaging organizations for serialization readiness.
January 5, 2014
Materials
Business process considerations for mixing serialized with non-serialized shipments
You might need to implement special business processes for handling serialized versus non-serialized shipment processing with your supply chain partners during piloting.
January 5, 2014
Traceability/Serialization
Validation considerations for serialization
As a rule of thumb, validation adds 25% to the cost of any changes required by serialization.
January 4, 2014
Traceability/Serialization
Impact on production line speeds and OEE
Of utmost concern to production/operations teams is the impact serialization will have on production line speeds.
January 4, 2014
Pharmaceuticals
A perspective on DQSA, preemption, and pedigree
Now that DQSA is law, any previous investments to meet California pedigree law can be repurposed to meet the new federal law.
January 1, 2014
Pharmaceuticals
Label and panel redesign considerations
Often left out of the equation in early pilot tests, many package design professionals have discovered the hard way that serialization has a deep impact on labels and panel design.
December 30, 2013
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