Start small enough to test
Pick one product family and an investigation your team needs to complete. A useful first question is: which inputs created this batch, and which customers received it? Map the physical process before deciding how software should represent it.
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Add a sourcing and evidence review
For a sourcing-focused pilot, map actual facilities, link material origins and custody, and assign owners to evidence gaps. Keep this data exercise separate from the framework-specific legal assessment. Use the market-access hub to find the separate EU and US guides.
Agree the pilot acceptance test
Choose a recent output and ask someone outside the pilot team to identify its input lots, events and destinations. Include a corrected record and a missing-data exception. Record how long the task takes and which relationships could not be reproduced.
Extend only after reviewing the gaps
Check whether failures came from identity mapping, capture practice, partner timing or evidence access. Fix recurring causes before adding more suppliers and facilities. The checklist cannot determine which legal rules apply to your products; assess those separately from the system pilot.