Chain of custody is the documented record of who had a product, when, and under what conditions, from origin to point of use. It sounds bureaucratic. In practice it is the difference between answering a question and guessing.
The test that matters
Imagine a question arises about a specific unit eighteen months from now. Can someone identify that unit, trace it back through every handoff, and describe the conditions it was kept in at each step?
If yes, you have chain of custody. If no, you have inventory.
What it is built from
- Lot identifiers that tie a physical unit to a record.
- Handoff records showing each transfer of responsibility.
- Condition monitoring for storage and transit.
- Receipt confirmation at each stage.
- Retention of those records for an appropriate period.
Why it protects everyone
It lets a supplier identify precisely which units are affected if an issue emerges, instead of acting on everything or nothing. It lets a clinician answer a patient's question with a fact. And it means that when something is fine, that can be demonstrated rather than merely asserted.