Validation & Qualification

Validation & Qualification


For purposes of clarity, validations are referred to throughout the corresponding literature and relevant documentation as qualifications, due to the fact that we are specifically engaged in assisting our clients with their Validation Process.

A true qualification package should…

  • Consist of calibration records of all instrumentation used during the qualification
  • Provide documented evidence the chamber’s instruments are in a current calibrated state.

Full Qualification services are typically described in terms of a three-part process… The Installation Qualification (IQ) is utilized for providing documented verification that all key aspects of the design, pro- curement, and installation adhere to the design intention.

The Operational Qualification (OQ) is utilized for providing documented verification that the systems and subsystems perform as intended at all anticipated operating ranges (normally performed with an unloaded chamber).

The Performance Qualification (PQ) is utilized for providing documented verification that the process does what it is intended to do, in the correct and anticipated manner (normally performed with either a simulated or actual product load in the chamber).

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