Equipment Validation Guides
Equipment qualification guides (IQ/OQ/PQ) provide reliable documentation to help you meet regulatory requirements and industry standards as part of the validation process. Upon completion, you can feel confident that your equipment is installed, operating, and performing according to manufacturer’s specifications.
What is equipment validation?
Installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) verifies and documents your equipment’s ability to meet manufacturer design specification for performance.
Installation Qualification (IQ)
Demonstrates documented evidence that the instrument is properly installed to manufacturer’s specifications. Documentation is provided in checklist format.
Operational Qualification (OQ)
Demonstrates documented verification that the installed equipment operates as intended and designed. It verifies that the functionality of the equipment meets the manufacturer’s operational specifications. Documentation is provided in checklist format.
Performance Qualification (PQ)
Provides documented verification that the equipment can perform effectively and reproducibly within performance specifications. An outline of suggested topics for performance qualification are provided.
Who should complete equipment validation?
Qualifications are required for laboratories and blood banks that operate within a quality management system, comply with global standards and/or follow country-specific regulations. Testing and documentation help ensure that equipment is working appropriately.
What Equipment Validation Guides are Available?
- Platelet Agitators
- Platelet Incubators
- Plasma Thawing Systems
- Ultra-Low Temperature Freezers
Note: It is the responsibility of the end-user facility or their designee to complete the equipment validation.
Are Equipment Validation Services available from Helmer Scientific?
To obtain your Equipment Validation Guide(s), please complete the form below: