Implementing a Serialization Database Across an Entire Enterprise.
With changing regulations, it may seem like there is a fire breathing dragon standing over your serialization project – or worse, you have yet to begin planning implementation. At this point, dispensers should have their projects complete. Manufacturers are required to be up and running this November. Yes – this year. November, 2017. No pressure!
With a rise in counterfeiting and diversion of drug products throughout the world, we understand why serialization is necessary. However, implementing a serialization database across your entire enterprise may seem like a daunting task. It doesn’t need to be. Below are tips to help you rise up out of the ashes and protect patient safety and your manufacturing operations:
Plan Ahead. Consider all levels involved – vision system, packaging line, database, inventory, and supply chain – and how your serialization system will integrate into them. Establish User Requirements and discuss the advantages and disadvantages each system provides to your operations.
Use an application that complies to GS1 standards. Bar codes, EPCs, and RFIDs are all options that can comply with GS1 standards. Ensure your system’s architecture utilizes standard numerical identifiers so it can identify, capture, and share information globally.
Test your system. Commission, qualify, and troubleshoot your serialization system once integrated to ensure it is working properly. Common issues include problems with lighting, edge detection, processing speed, and OCR issues. Resolve these glitches before they become a problem.
Utilize experts. Whether internal to your organization or independent experts, you will benefit from including team members who have implemented serialization projects successfully. The added knowledge and experience will help anticipate potential issues that might rear their ugly heads throughout the process.
Chameleons blend seamlessly within their environments. Your serialization system should do the same. Upfront planning and experienced personnel on your implementation team will help you tame the dragon and comply with new regulations. Don’t get burned. Turn your serialization dragon into a chameleon that blends into your processes to add an additional layer of protection to your manufacturing operations and protect patient safety.
CAI can provide those experts to help make the transition from dragon to chameleon much smoother. If you're ready to make the transition, contact John Hannon, Business Area Lead for Automation and Information Technology at (336) 558-6025 or by email [email protected]