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Installation Qualification (IQ)

Do you need an Installation Qualification (IQ) documentation? The qualification document Installation Qualification (IQ) is part of the quality management system at the company KNAUER. and it is free of charge. In case of a request, the Technical Support of KNAUER or from a provider authorized by KNAUER performs this functionality test during the installation.
The IQ is a standardized documentation that includes the following:

  • Confirmation of flawless condition at delivery
  • Check if the delivery is complete
  • Certification on the functionality of the device

Operation Qualification (OQ)

The Operation Qualification includes an extensive functionality test according to KNAUER standard OQ documents. The Operation Qualification is a standardized document and free of charge. It is not part of the delivery, please contact the Technical Support in case of request.
The Operation Qualification includes the following:

  • Definition of customer requirements and acceptance terms
  • Documentation on device specifications
  • Device functionality check at installation site
Test intervals: To make sure that the device operates within the specified range, you should test the device regularly. The test intervals are dependent on the usage of the device.
Execution: The test can be carried out either by the Technical Support of KNAUER or from a provider authorized by KNAUER (for a fee).

Performance Verification (PV)

Definition: The document Performance Verification (PV) is part of the quality management system of KNAUER. The Performance Verification includes a reproducibility test of an AZURA Analytical HPLC system and must be purchased from the manufacturer.
The PV is a standardized KNAUER document and includes the following:

Goals: The system runs reliably within the documented specifications and the PV is a summary of the results with comments and evaluations.
Target group: The test can be carried out either by the technical support of KNAUER, from a provider authorized by KNAUER or by the customer.

Material certification

Upon request customized material certification for all wetted parts with varying degrees of complexity from manufacturer statement (only material) to full documentation (e.g. material certification 3.1, FDA compliance statements).

Note: retrospective material certification is not possible.

Factory acceptance test (FAT) /
Site acceptance test (SAT)

The factory acceptance test (FAT) refers to the functional test that is performed by upon completion of the manufacturing process to prove the equipment has the same specification and functionality that indicated in the datasheet, specification and purchase order. We are experienced in establishing such test procedures together with you before your equipment is delivered.

The acceptance of the equipment at your site (site acceptance test, SAT) is also possible: A technician comes to you and ensures that everything works to your utmost satisfaction. In addition, we can integrate the equipment into the existing production environment, if necessary.

Capillary labeling

Complex HPLC systems with a myriad of valves and variable flow paths can be somewhat confusing. We offer professional capillary labeling upon request, to aid end-users in everyday use.

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