Though DSCSA Law Remains Unchanged, Compliance Penalties are Delayed Until Nov. 2018. Pharma Companies will be able to Implement Far-reaching Serialization Solutions
East Windsor, NJ – As the U.S. pharmaceutical industry breathes a collective sigh of relief, Adents, the number one provider of versatile and easily deployable serialization and track-and-trace software solutions, is urging pharma manufacturers to take full advantage of the Drug Supply Chain Security Act’s one-year enforcement postponement.
Though the law itself remains unchanged (a formal amendment would require an act of Congress), news recently broke that penalization for the law’s key facets – most crucially, the necessity of printing a unique product identification code on all Rx units of sale and homogenous cases distributed domestically – will be put off until November 2018. Leading up to the announcement, however, an alarmingly high number of pharmaceutical manufacturers and CMOs did not have serialization solutions in place sufficient to meet the initial November 2017 deadline.
“With the postponement, companies who have not yet completed the serialization process stand to gain the most,” said Christophe Devins, CEO of Adents. “As awareness grows of the complexity and interconnectivity of the serialization process, pharma manufacturers are realizing the importance of modularity and flexibility in the solutions they choose.”
“And that,” he continued , “is where Adents comes in.”
According to Adents, the delay in the enforcement date provides valuable time for pharmaceutical manufacturers to look beyond short-term compliance needs and consider long-term solution viability. Considering what remains a muddied landscape, desired systems will likely trend toward more flexible, hardware-agnostic serialization solutions that can adapt or scale up to meet future track & trace mandates, as well as help improve business practices.
For those who had been rushing toward compliance, then, the delay affords time to rethink the overall process, such as incorporating tools that can better utilize – for the sake of production improvements and personnel allocation – the troves of data that serialization mandates require be tracked and stored for reporting purposes.
The Adents serialization and aggregation suite of software enables companies to achieve traceability and documentation compliance easily, addressing both current and emerging regulations while also minimizing impact on production processes and productivity. An ideally standardized approach, Adents solutions are extremely flexible, scalable, and quick to deploy because configuration takes place completely at the site level, making per-line configuration unnecessary. Adents serialization software is hardware agnostic, meaning it is compatible with a wide range of equipment.
“In light of the enforcement postponement, we’re looking to educate customers on the versatility and scalability of Adents serialization solutions,” continues Mr. Devins. “The beauty of our software suite is the way it enables companies to comply with short-term serialization mandates while remaining adaptable for future regulations. Above and beyond that, our solutions allow them to derive additional business value from the tremendous amount of data that gets generated for serialization purposes.”
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Adents is a leading provider of premier serialization software solutions for unique product identification and traceability. Adents helps pharmaceutical companies and contract manufacturing organizations (CMOs) adapt to market changes and comply with regulations on drug traceability.
Adents Seriza, a serialization solution for manufacturing sites, has been selected as a preferred solution by Siemens for its customers. Adents Prodigi, a cloud solution jointly developed with Microsoft and powered by Azure technologies, allows for secure data exchange and helps leverage the power of serialization data.
Adents operates globally, with offices in the United States, Europe and Asia and with a worldwide network of solution partners. For more info, visit www.adents.com.
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