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Saudi Arabia Compliance

TraceLink’s end-to-end solution covers a range of Saudi Food and Drug Authority (SFDA) compliance scenarios, including product registration, warehouse operations and distribution, bulk package transfers, and drug product status to give your compliance team comprehensive visibility into your Saudi Arabia operations. TraceLink uses configurable workflows to integrate into Package Transfer Service (PTS) to manage the exchange of aggregation information across the supply chain.

Benefits

  • Data integration. TraceLink provides an integrated compliance reporting solution, including product serialization data, master data, and aggregation data.
  • Automated workflows. Automated reporting to SFDA can be triggered by supply chain events, replacing manual data exchange and reporting via CSV files or spreadsheets.
  • Regulatory expertise. As your global compliance software partner, TraceLink monitors evolving SFDA regulations to support your assessments of how compliance impacts your business. 
  • PTS integration. TraceLink integrates into PTS with configurable workflows. 

TraceLink’s Saudi Arabia Compliance application monitors TraceLink’s Serialized Operations Manager (SOM) application for reportable events. For example, if a delivery including a Saudi Arabian product is created in SOM, the application generates a report and sends it to the Saudi Arabia track and trace system. Compliance events and data queries include:

  • Product registration
  • Warehouse operations and distribution
  • PTS Support: bulk/aggregated product information exchange
  • Check product status

Applications 

Product Serialization 

A complete suite of proven modules allows companies to create and exchange serial numbers as well as manage serialized operations: Serial Number Manager, Serial Number Exchange, and Serialized Operations Manager.

Saudi Arabia Compliance 

TraceLink’s Saudi Arabia Compliance application provides out-of-the-box automated event workflows to trigger report generation directly from serialization operations. Send, search, and view compliance reporting messages sent directly to the Saudi Arabia Regulatory System and receive response messages with alerts for negative responses for all compliance reports.

Smart Inventory Tracker

Serialization and aggregation management for warehouses and distribution centers, including serialized shipping and receiving and exception management as well as integration with Serialized Operations Manager to trigger associated warehouse events.

Automated Validation Manager

Automated execution of test scripts and documentation to support continual software compliance aligned with GxP standards, including validation materials for Saudi Arabia solution components, Smart Inventory Tracker and Product Serialization. Automated Validation Manager addresses the requirements of the Performance Qualification (PQ). With Installation Qualification (IQ) and Operational Qualification (OQ) support also included in the SaaS license, TraceLink reduces the cost and time associated with validating your compliance solution. 

TraceLink University 

Give your team the training and skills to support your compliance and business requirements. Enhance the value of your TraceLink solutions with instructor-led courses, self-paced learning, and hands-on experiences that go beyond core product training. Select the support that aligns with the needs of each team member—from individual contributors and department managers to administrators. 

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