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A check performed before each batch to confirm the whole system is fit to run is a system ______ test.

  • A.validation
  • B.qualification
  • C.calibration
  • D.suitability

Answer: D

This is a system suitability test. Validation establishes a method's performance once, qualification demonstrates that an instrument is installed and operating correctly, and calibration relates a response to a concentration. Four activities on four different timescales, and using the right term matters because a regulator will ask which of them was performed.

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