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Tips to Beat the Clock on DSCSA Serialization

Until recently, much of the long-term value manufacturers and packaging operations can gain from serialization has been unrealized. It’s time to tap into a goldmine of data and gain visibility into critical interactions across trading partner networks.

Pharmaceutical CMOs and re-packagers have until November 2017 to comply with new item-level serialization regulations. Shown here are serialized packages with unique identifiers in 2D barcodes that help track the product through the supply chain and verify product legitimacy. (Image courtesy of Verify Brand)
Pharmaceutical CMOs and re-packagers have until November 2017 to comply with new item-level serialization regulations. Shown here are serialized packages with unique identifiers in 2D barcodes that help track the product through the supply chain and verify product legitimacy. (Image courtesy of Verify Brand)

By the time you’re reading this, you’ll have less than a year to deploy an item-level serialization solution across your packaging facility. By not meeting DSCSA requirements, Contract Manufacturing Organizations (CMOs) and packagers are at risk for penalties. However, you’re also missing a huge opportunity to meet pharma brands’ needs for compliance data and reporting. Here are tips to make sure you can meet upcoming requirements and take advantage of the competitive benefits serialization can offer.

Fast and efficient deployment

Not all serialization solutions are created equal. With less than a year to go, you need a platform that can be deployed quickly and that comes from a partner with transparent costs and timelines. Below are some key features to look for that offer value beyond regulatory compliance.

• Hosted solution: Building a new system or upgrading on-premises equipment to support serialization can be time-consuming and expensive. Instead, most companies are leaning toward a hosted solution in the cloud that is secure and cuts deployment time. This approach also eliminates costs for hardware, maintenance and management.

• Standards-based: Time is running out for integrations that require lengthy customizations. While very few integrations will be “plug and play,” those that leverage EPCIS, the standard in serialization data exchange, allow you to quickly integrate with your trading partners. As your system evolves, universal standards will help safeguard these critical partner connections.

• User-friendly interface and reporting: Training can take time, so choose a serialization platform with intuitive features and user-friendly design to reduce staff training and lower the adoption curve. In addition, a serialization platform with built-in reporting tools allow you to quickly identify and report on regulatory compliance requirements, as well as report on the health of your supply chain.

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