
Automation System Qualification
Evidence your Automation System is suitable for its intended use
Automation Qualification documents that your automated system is installed correctly and functioning per specification. Automation Qualification tests the characteristics and functions of the system, not the output (product) produced by the system. Falling within the scope of Validation, completion of this step ensures that your system is ready to tested as part of a process in conjunction with other systems (process performance qualification).
Services
- Validation Project Management
- Validation Plan Development and Execution
- Change Control Documentation
- System Assessment (GxP)
- Risk Assessment & Mitigation
- User Requirements (URS) Development
- Design Specification Documentation (compilation of vendor documents)
- Maintenance Plan Implimentation
- Validation Issue Resolution
- Design Review
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Requirements Traceability (RTM)
- Validation Report Development
- System SOP Development
- System Training
Automation System Examples
Automated Equipment is considered to be highly configurable or bespoke systems.
- CIP Systems
- Product transfer Systems
- Process Automation Systems
- Equipment with custom sequential logic
- Distributed Control Systems
- Building Automation Systems
- Building Management Systems
- Purified Water Systems
- Utility Control Systems