The new Supply Chain Work Management functionality enables seamless resolution of supply chain exceptions and ensures compliance with regulations such as DSCSA.
BOSTON, September 1, 2023 /PRNewswire/ — TraceLink Inc., the leading digital network platform company enabling end-to-end product orchestration by connecting more than 290,000 healthcare and life sciences entities through its B2N Integrate Network- Once™, today announced a new feature, Supply Chain. Work management for compliance exceptions. This game-changing capability addresses the urgent need for compliance with the U.S. Drug Supply Chain Security Act (DSCSA), which requires collaborative resolution of exceptions between trading partners prior to the sale of products to subsequent trading partners.
Supply Chain Work Management for Compliance Exceptions by TraceLink provides an automated and efficient solution for managing, reconciling and resolving compliance exceptions between trading partners. Building on the comprehensive guidance provided by the Healthcare Distribution Alliance (HDA) for capturing, categorizing and tracking DSCSA exception data, TraceLink developed this exception management capability to ensure compliance with federal laws, FDA regulations and industry guidelines while accelerating resolution time to keep products moving throughout the supply chain. This feature is also available to help with exception handling in other global markets.
To ensure this new functionality launches with broad cross-industry representation, TraceLink has already signed over 25 supply chain labor management customers for compliance exceptions, now focused on working with an initial target group of more of 700 critical supply partners. By adopting supply chain work management for compliance exceptions, supply chain partners can collaborate seamlessly, resolve issues quickly, and maintain continuity and efficiency in managing compliance exceptions. the supply chain. With Supply Chain Work Management for Compliance Exceptions, supply chain members gain immediate access to:
- A market-leading interoperable network of more than 290,000 authenticated and pre-integrated trading partners.
- Standards and Process to identify and resolve exceptions in a collaborative and agile manner.
- Continuity and efficiency to collaborate with trading partners in managing variances in the supply chain in a centralized and user-friendly manner.
- Electronic and automated rapid problem resolution capabilities, thereby minimizing supply chain latency.
- Integrate existing systems encounter the exception and automate the creation of a given exception to streamline processes.
- Continuous compliance with federal laws, FDA regulations and industry guidelines through maintenance of documentation, data requirements and business practices consistent with regulatory frameworks.
“Compliance exception management represents a key capability within our comprehensive compliance toolkit,” said Shabbir Dahod, CEO and President of TraceLink. “We recognize the critical importance of DSCSA compliance and the challenges trading partners face in effectively resolving exceptions. Our new capability gives supply chain stakeholders the tools they need to collaboratively address exceptions, ensuring product integrity and patient safety.
TraceLink recognizes the importance of quickly and reliably resolving DSCSA exceptions, a key element in why the FDA recently requested a 12-month stabilization period for DSCSA compliance. TraceLink has invested heavily in new capabilities to equip trading partners with the tools they need to collaboratively address these exceptions. Key features of the new Compliance Exception Management functionality within the TraceLink Supply Chain Work Management solution suite include the ability for application owners and supply chain partners to:
- Create a compliance exception.
- Submit an exception to a supply chain partner or internal site.
- Add detailed information about the affected product, including lot number, expiration date, and a list of affected serial numbers.
- Include a complete list of external transactions associated with the exception.
- Associate entities such as Shipped From, Shipped To, and others with the exception.
- Attach relevant files to the exception for full documentation.
- Facilitate collaboration between users through comments and communication within the platform.
- Facilitate the updating of original compliance documentation based on the results of the exception management process.
With the introduction of Supply Chain Work Management for Compliance Exceptions, TraceLink continues to lead the way in digital supply chain compliance and innovation, enabling life sciences and healthcare companies to navigate effectively navigate complex regulatory landscapes while ensuring product integrity and patient safety.
For more information about TraceLink and the Supply Chain Work Management solution, visit https://www.tracelink.com/products/supply-network-orchestration/supply-chain-work-management.
TraceLink is a leading provider of digital supply chain solutions that deliver unprecedented visibility, enabling businesses to protect patients, ensure compliance and optimize their supply chain operations. TraceLink’s cloud platform provides a single point of information sharing and collaboration for all supply chain partners, leveraging advanced analytics and machine learning to generate actionable insights. With TraceLink, companies can gain end-to-end visibility of the supply chain and forge stronger connections with their partners, ensuring the availability and integrity of life-saving medicines for patients around the world.
SOURCE Tracelink, Inc.