Obtain Drug Supply Chain Security Act (DSCSA) Compliance Ahead of Deadline

RESTON, Va., July 31, 2024 (Newswire.com) - Softeon, the only tier-1 warehouse management system (WMS) provider focused on optimizing warehouse and fulfillment performance to increase operational efficiency, announced its commitment to assisting pharmaceutical stakeholders in achieving compliance with the 2023 requirements of the United States Drug Supply Chain Security Act (DSCSA). 

As a member of the Healthcare Distribution Alliance (HDA), Softeon is committed to ensuring that stakeholders in the pharmaceutical industry are ready to meet enforcement of stringent regulatory requirements that will go into effect in November 2024. The Drug Supply Chain Security Act plays a critical role in safeguarding public health by strengthening the integrity of the pharmaceutical supply chain and reducing the risks associated with counterfeit and unsafe drugs.

By establishing requirements for tracking and tracing prescription drugs as they move through the supply chain, the act aims to reduce the risk of harmful drugs reaching patients. 

Starting in November 2023, manufacturers, repackagers, wholesale distributors, and dispensers will be required to trace each drug product through its distribution history down to the individual package level, leading to the ability to quickly and accurately identify and remove potentially unsafe drugs from the market.

The pharmaceutical supply chain faces several challenges in adhering to DSCSA regulations - these include ensuring data quality, integrating various systems, and utilizing modern technology.

Adopting universal standards, such as GS1 for storing and processing product information seamlessly, is vital. This adherence to GS1 standards facilitates the serialization processes and enables the tracking of lot numbers, serial numbers, and expiration dates for every product, leading to comprehensive traceability from manufacturing to consumption. 

With over a decade of industry experience, Shyam Krishna, Vice President of Healthcare Solutions at Softeon, highlights the critical importance of taking proactive measures and establishing strategic partnerships with WMS providers to achieve compliance and operational efficiency, especially with the advent of rapid drug discovery due to AI and also the next generation of automation and robotics adoption in distribution centers.

“The rise of item-level visibility solutions is driven by the increasing consumer demand for product authenticity and the need for resilient supply chains,” said Shyam Krishna, Vice President of Healthcare Solutions at Softeon. “Our advanced WMS solutions address these needs, ensuring real-time tracking and robust data integrity, which are crucial for compliance and efficiency in the pharmaceutical industry.” 

• Product Tracing: To comply with FDA regulations at every step of the supply chain, Softeon’s WMS solutions provide the capability to handle all necessary reporting after drugs are picked, packed, and shipped. This includes the first phase of DSCSA Lot level tracking such as Transaction Information (TI), Transaction history (TH) and Transaction Statement (TS) and the new Lot/Serial aggregation messages to handle the hierarchy of product and package information from a Pallet, case or tote level to the lowest unit level, and their dispositions.
• Product Identification, Verification, and Reporting: Softeon’s WMS seamlessly integrates with top serial number repository managers worldwide, such as Axway, TraceLink, and other vendors for product verification during inbound and outbound product flows and during returns and recalls.
• Temperature and Time-Sensitive Inventory Management: Managing temperature-sensitive and time-sensitive inventory is crucial in the pharmaceutical industry. Softeon’s WMS ensures that drugs are handled appropriately, preventing spoilage and ensuring efficiency - both in highly automated and RF device based cold chain pick, pack and ship environments with rapid outbound audits for DSCSA 2023 compliance, while adhering to “Time out of environment” rules and constraints.

Pharmaceutical manufacturers, warehouse managers, and supply chain professionals must act now to comply with the upcoming DSCSA regulations in order to safely deliver medicine and other healthcare products to patients.

Softeon’s expertise and advanced WMS solutions provide the necessary tools and support to navigate the complexities of the pharmaceutical supply chain. 

To learn how to ensure compliance with DSCSA regulations and bolster brand reputation, register for Softeon’s “How to Comply With - and Benefit From - the Drug Supply Chain Security Act” webinar on August 20 with Tech Mahindra. 

Softeon will also be exhibiting at the LogiPharma trade show from September 23-25 in Boston. Visit us at Booth #122 to discuss this important topic.

ABOUT SOFTEON

Softeon is a WMS provider focused exclusively on optimizing warehouse and fulfillment operations. For over two decades now, we have been helping our customers succeed. Investing in R&D enables us to develop software to solve the most complex warehouse challenges. Softeon is laser-focused on customer results, with a 100% track record of deployment success. We believe warehouse leaders shouldn’t have to settle for a one-size-fits-all all approach to technology. For more information, please visit www.Softeon.com.

Source: Softeon