Process

Equipment Qualification

The Equipment Qualification Process

Definitions:

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
conditions.

Performance Verification (PV): A testing procedure designed to test the analytical
instrument’s functional performance to factory
published specifications.

Service Benefits:
  • 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
    specification.
  • 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
    complete record.
  • 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.

 

Our chromatography services include: moving, installations, repairs, maintenance, training, method development, and chromatography equipment qualification..