Traceability

Definition

Traceability is the capability to trace a batch's complete history, including materials, equipment, personnel, and process steps, both forward through distribution and backward to originating raw materials. It's closely related to, and sometimes used interchangeably with, batch genealogy.

Benefits

Strong traceability, enabled by structured EBR data, is what allows a manufacturer to respond quickly and precisely to a quality issue, whether that means identifying every batch affected by a specific raw material lot, or confirming which equipment and personnel were involved in a specific production run.

Use Case

A quality investigation needs to determine every batch produced using a particular calibration-flagged piece of equipment over the past six months. Because equipment usage is captured within each electronic batch record, the EBR system can generate this list directly, rather than requiring a manual review of paper logs across dozens of batches.

Frequently Asked Questions (FAQ)

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Related Terms

• Genealogy/Traceability
• Chain of Custody
• Serialization