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Supply Chain Work Management for Compliance Exceptions

Collaborate with trading partners on a single platform to identify, analyze, triage, and resolve DSCSA compliance exceptions

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Product overview

Resolve compliance exceptions with minimal disruption

Supply Chain Work Management for Compliance Exceptions enables companies to rapidly identify, onboard, and engage supply chain partners in a multienterprise process to intake, triage, and resolve both internal and external issues associated with compliance exceptions.

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With Supply Chain Work Management for Compliance Exceptions, you can:

Collaborate with partners to resolve exceptions from a central platform

Create custom cross-company workflows to accelerate exception resolution

Capture insights into exceptions to improve operational processes

Industry challenges

New traceability requirements drive an influx of exceptions

The DSCSA EDDS requirements mandate the electronic exchange of unit-level product data. This greatly increases the amount of data exchanged between trade partners, with any error generating a compliance exception that must be resolved before product can be moved. Challenges include:

Increased exception volume

The transition to serialized transaction information exchange will significantly increase exception volume. As many as 1% of shipments may have an exception.

Increased exception volume
Supply chain disruption

Pharmaceutical products cannot be shipped or sold until exceptions are resolved, which hinders business operations and may even threaten patient safety.

Supply chain disruption
Inefficient collaboration tools

Exceptions are typically managed over phone, email, and shared spreadsheets, which increases the risk of miscommunication and impedes collaboration efficiency.

Inefficient collaboration tools

SCWM for Compliance Exceptions benefits

Automate compliance exception management and speed successful resolution

Integrate Once, Interoperate with Everyone™

Increase scalability

Maintain continuous compliance

Ensure supply

use cases

Product benefits

Integrate Once, Interoperate with Everyone™

TraceLink customers can collaborate on exceptions with all partners in one central location, streamlining resolution processes and ensuring process adherence. All trading partners are connected to each other through a single integration to the TraceLink network.

Supply chain performance

Product benefits

Increase scalability

The TraceLink architecture is designed to scale to handle the large increase in data exchange required by the DSCSA 2023 EPCIS mandate across the pharmaceutical/healthcare supply chain and support collaborative reporting and resolution of exceptions.

Analytics

Product benefits

Maintain continuous compliance

TraceLink works with industry and government organizations including the HDA and the FDA to ensure Supply Chain Work Management is updated to reflect the latest standards. Additionally, Supply Chain Work Management can easily be customized to meet the unique exception resolution requirements of supply chain partner relationships.

Analytics

Product benefits

Ensure supply

The TraceLink network enables scalable integration of all partners with real-time collaborative capabilities to resolve exceptions quickly and ensure products do not get stuck in quarantine.

Capabilities

Digitalize exception management processes with partners

Create digital networks with trade partners to exchange business process information and accelerate cross-company sharing of supply chain data.

Configure workflows

Customize data views

Configure alerts

Stay connected

MINT
  • Configure internal triage processes to meet your unique needs with impact assessments, alerts, and deadlines.
  • Multienterprise tasks enable cross-functional and cross-company resolution processes to be sequenced and assigned to subject matter experts based on exception type to ensure rapid response to the customer.
Analytics
  • Exceptions can be quickly created by manufacturers or their customers through the user interface, API, or email, and exceptions can be classified according to HDA guidelines.
  • Real-time dashboards provide managers and customers with visibility into exception priority, due date, and status, as well as reporting and historical data to ensure prompt resolution.
For_Internal_94
  • Configure internal stakeholder email notifications for new exception reports and alert messages received.
For Internal 5
  • Collaborate with customers to rapidly resolve exceptions in real time on a secure, common platform with permissioned views.
  • Communicate resolution details back to internal teams and customers so products can be released from quarantine.

Industry voices

Build a stronger network

See what our customers and partners are saying about TraceLink.

Hear what our customers and partners are saying about SCWM for Compliance Exceptions.

As we gear up for the November 2024 deadline, TraceLink’s ‘Integrate Once, Interoperate with Everyone™’ strategy has streamlined the onboarding process for our trading partners. With minimal effort from our staff, we can swiftly connect with partners, freeing up our resources to concentrate on customer assistance and ensuring our warehouse systems and operations align with our DSCSA obligations.

Mike Shaw

Vice President of Information Technology

Value Drug Company

Explore related products

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Supply Chain Work Management SCWM for Product Recalls
Supply Chain Work Management SCWM for Incidents
Supply Chain Work Management SCWM for Change Requests
Supply Chain Work Management SCWM for Document Reviews

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How can we help you?

Connect with our experts and discover how TraceLink Supply Chain Work Management solutions can meet your unique business needs.

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