MiSeq FGx IQ/OQ/PQ Services

MiSeq FGx Installation, Operation, Performance Qualification Services

Some laboratories require that all instruments are installed, operate, and perform properly. Verogen provides specific qualification services to ensure your instrument is set-up and functioning as it is.

Installation Qualification and Operation Qualification

During an Installation Qualification, the Field Service Engineer verifies:

  • The customer has received the MiSeq Instrument documentation
  • The correct instrument and components were shipped and is being qualified
  • The physical elements of the instrument are properly installed
  • The instrument meets all acceptance criteria

During an Operational Qualification, the Field Service Engineer verifies:

  • The correct instrument is being qualified
  • All important transport components are functioning, and that the motion components meet Verogen specifications
  • All imaging module components are functioning properly and that the optical system meets Verogen specifications
  • The fluidics system in the instrument meets Verogen specifications
  • The thermal system in the instrument meets Verogen specifications
  • Software is installed on the system
  • Instrument meets all Verogen specifications

The customer will receive a certificate with the specifications for the MiSeq FGx at the successful completion of the IQ/OQ protocol. This service can be purchased at time of installation or at any time after installation.

Performance Qualification

In addition to the Installation and Operational Qualification, customers may also request a Performance Qualification. During the Performance Qualification, the Field Service engineer:

  • Verifies the software installed on the instrument
  • Records the lot numbers and expiration dates of the consumables used to perform the PhiX run
  • Verifies that the instrument meets Verogen PhiX run specifications
  • Verifies that the instrument meets all Verogen specifications

PhiX results will be provided to the customer at the end of the Performance Qualification. The Performance Qualification may be purchased as a service at any time.

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