Regulatory Affairs • Global Registration

International Regulatory Requirements - Data Transfer & Tracking

Duration: 1 month • Role: Regulatory Affairs Specialist

Transferring Canada, Mexico, and EMA BuDI form data for Healix Advance and RigidFix showed that data transfers between systems need a validation pass before they're trusted. A silent transcription error at this stage propagates into every downstream registration decision.

Context

Registration data for Canada, Mexico, and the EMA BuDI form for Healix Advance and RigidFix needed to move into the international regulatory tracker. Moving it without a verification pass risked carrying a transcription error straight into the master record.

Global Registration Data Transfer Registration Tracker

Primary Risks Identified

  • A country's registration status going stale in the tracker (e.g. certificate expired or a requirement changed) without anyone noticing until a shipment is blocked

Testing Approach

Cross-checked each country's registration status and certificate data against the source registry and Salesforce record, corrected any discrepancies found, and updated the master tracker.

Salesforce Registration Tracker Source Document Verification

Outcome

Completed the data transfer into the international regulatory tracker and verified it against the source documents for accuracy.

Key Lessons

Data transfers between systems need a validation pass before they're trusted, because a silent transcription error at this stage propagates into every downstream registration decision.

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