Chain of Custody

Definition

Chain of custody refers to the documented, unbroken record of how data, materials, or samples are handled, transferred, and stored from the point of generation through to final disposition. In regulated manufacturing, maintaining chain of custody helps establish that data or materials have not been tampered with or substituted at any point.

Benefits

A clear chain of custody strengthens the credibility of both physical samples and electronic data during audits and investigations, since it demonstrates continuous, traceable control rather than gaps where tampering or error could have occurred undetected.

Use Case

A stability sample is pulled for testing at a specified interval. The chain of custody log records who collected the sample, how it was transported, and who received it in the lab, ensuring that if a result is later questioned, the full handling history can be reviewed.

Frequently Asked Questions (FAQ)

Related Terms

• Audit Trail
• Data Integrity
• Traceability