The Equipment Qualification Process
Installation Qualification (IQ): Establishes the instrumentation was received as
specified and documents the proper installation and
operability according to manufacturer standards.
Operational Qualification (OQ): The process of demonstrating that an instrument
will function according to the manufacturer’s
operational specifications under normal laboratory
Performance Verification (PV): A testing procedure designed to test the analytical
instrument’s functional performance to factory
- Provide the evidence needed to satisfy the requirements of international
regulatory and quality agencies.
- Eliminate the need for laboratory validation specialists and quality
assurance/quality protocols for the tested instruments.
- Ensure that the instrument is performing according to the manufacturers
- Follow the same equipment qualification procedures and provide uniform documentation from laboratory
to laboratory, worldwide.
- Decrease the risk of financial loss caused by noncompliance.
- Ensure confidence in the integrity of their measurements, with traceable
documentation that give them, their customers, and regulatory agencies a
- Trained and certified service engineers perform the equipment qualification procedures.
- SCC provides calibrated and traceable tools, testing equipment and standards
needed to qualify the instrument.
- SCC is factory trained in the operation of the instrument.