Equipment Log / Equipment Qualification

Definition

An equipment log records the usage, cleaning, maintenance, and calibration history of manufacturing equipment. Equipment qualification is the documented process of verifying that a piece of equipment is properly installed (IQ), operates correctly (OQ), and performs consistently under real production conditions (PQ) before it's used for GMP manufacturing.

Benefits

Linking equipment logs and qualification status directly into the EBR ensures a batch cannot be started using equipment that's out of calibration or pending qualification, closing a common gap that exists when equipment records are tracked separately from production records.

Use Case

Before allowing an operator to select a piece of equipment for a batch step, the EBR system automatically checks the equipment's current calibration and qualification status, blocking selection if the equipment is overdue for calibration.

Frequently Asked Questions (FAQ)

Related Terms

• System Validation Lifecycle
• Line Clearance