Certificate of Analysis (CoA)

Definition

A Certificate of Analysis is a document, issued by a supplier, quality control lab, or manufacturer, that confirms a batch of raw material or finished product has been tested and meets its defined specifications. CoAs are typically reviewed and retained as part of batch documentation to support both incoming material acceptance and finished product release.

Benefits

Digitizing CoA review and storage within an EBR or QMS reduces the manual burden of matching paper certificates to incoming shipments, and creates a searchable record that speeds up both supplier audits and product recalls, should traceability back to a specific material lot be required.

Use Case

A quality technician receiving a raw material shipment uploads the supplier's CoA into the system, which automatically checks reported values against predefined acceptance criteria and flags any out-of-range results before the material is approved for use in production.

Frequently Asked Questions (FAQs)

Related Terms

• OOS (Out of Specification)
• Batch Release
• QMS (Quality Management System)