ABSTRACT
USP <1058> adopts the 4Q lifecycle using these four phases: design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). The process is illustrated in Fig. 3.1. In the DQ phase, user requirements are compared with the vendor’s specifications. In addition, users conduct an assessment of the vendor. In the IQ phase the user’s environment is checked if it meets the vendor’s environmental specifications. The instrument is installed according to the vendor’s recommendations and correct installation is verified and documented. OQ checks if the instrument conforms to the functional specifications, as defined in the DQ phase. PQ verifies that the complete system works for selected applications. Preventive maintenance activities and controlled changes also are part of this phase. All activities are defined in a validation or qualification plan and results are documented in a summary report. Configurations are defined in the requirement specifications document for configurable computerized SFC systems. They are implemented during the installation and tested as part of OQ.
