Four Key Considerations for Selecting a Serialization Solution

The first DSCSA serialization deadline is exactly 19 months from today. If your pharmaceutical company sells prescription drugs in the U.S. – or your CMO works with a brand that does - you must be prepared to serialize product at operational scale by November 27, 2017. If you are not ready, your ability to sell medications into the U.S. will be at high risk.

As part of our DSCSA GPS: Your Roadmap to November 2017 Serialization campaign, we’ve talked about assessing your requirements, products, and timelines, and initiating collaborations with your trade partners and internal teams. The next critical task is choosing your serialization infrastructure and solution partner so that you can move forward in earnest. This is a momentous decision: your solution partner will play a critical role in your ability to successfully meet DSCSA and other global serialization challenges, and to ultimately move product into your target markets.

To protect your business, there are four critical success factors you must consider as you choose solution candidates and evaluate their capabilities:

• Network: How will your platform implement trade partner and government data exchange requirements rapidly, and at the lowest possible cost? 
• Scale: Has the infrastructure you choose proven it can handle a massive volume of serialized information and transaction processing, and do so in an operationally efficient manner? 
• Compliance: Can your partner enable you to rapidly adopt all emerging country requirements, and adapt for pre-existing ones that evolve? 
• Ensure Supply: Ultimately, will your solution lower the compliance, implementation, and integration risks for global supply with a mission-critical, highly available supply chain service? 

Over the next eight weeks, we’ll walk through how to select solution candidates; the pros and cons of using an RFP process; criteria for narrowing the field; what to look for in a product demonstration; how to collect meaningful feedback from references; evaluating the total cost of ownership; and making a final selection. Follow along and by the end of June, your company should be primed to forge one of the most important partnerships you’ll ever make.