STEP 01
URS
Defines the system requirements from an operational and process perspective. Establishes a clear, controlled baseline of what the inspection system must achieve within the production and quality environment.
Methodology
Validation Framework
A structured validation lifecycle designed for regulated machine vision systems, ensuring compliance, traceability, and performance from concept to production.
STEP 02
Risk Assessment
Defines the system requirements from an operational and process perspective. Establishes a clear, controlled baseline of what the inspection system must achieve within the production and quality environment.
STEP 03
Design Specification (Hardware, Software, and Integration Design)
Details the complete system architecture, including hardware configuration, software logic, communication protocols, and integration with production equipment and quality systems.
STEP 04
Factory Acceptance Testing
Structured FAT in a controlled environment with traceable evidence.
STEP 05
Installation Qualification (IQ)
Verifies that all system components are installed according to approved design specifications, manufacturer requirements, and site infrastructure constraints.
STEP 06
Operational Qualification (OQ)
Confirms that the system operates according to defined functional requirements across its full operational range, under controlled and repeatable test conditions.
STEP 07
Performance Qualification (PQ)
Demonstrates that the system performs consistently in real production conditions, ensuring compliance with defined quality, speed, and detection performance criteria.
STEP 08
Production Release
Release to manufacturing with full documentation about Calibration Procedures, Preventive Maintenance, Training Records, Audit Ready Package, and Lifecycle plan.