ultraflextreme maldi-tof/tof mass spectrometer

Compliance Service

Fulfilling all regulatory requirements such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Verification (PV).

Each step of instrument installation including all necessary test procedures is documented by our factory trained and certified engineers.

The Bruker Compliance Service helps you to achieve and perform the regulatory compliance of your MS instrument.

Benefits of Bruker compliance service:

  • Factory trained and certified engineers with many years of instrument experience
  • Bruker takes care of all necessary documentation
  • Requalification service after instrument repair if necessary
  • Time and cost reduction through the use of optimized procedures.

Installation Qualification (IQ)

Installation Qualification (IQ) establishes that the instrument is received as designed and specified. It has been properly installed in the selected environment.

All IQ requirements need to be satisfied and completed before the OQ/PV can commence.

The IQ has to be renewed after moving the instrument to another location or laboratory.  

Major aspects are:

  • Documentation
  • Scope of delivery / Completeness
  • Specification / Identification
  • Site Preparation
  • Supply connections
  • Safety requirements
  • Accessibility for instrument service 

Operational Qualification / Performance Verification (OQ/PV)

Operational Qualification / Performance Verification (OQ/PV) ensures that the instrument functions correctly to the manufacturer’s specification. OQ/PV helps to qualify the analytical system for correct operation in the customer’s laboratory. The OQ/PV has to be renewed after moving the instrument to another location or laboratory. After a preventive maintenance (PM) service or a significant instrument repair the OQ/PV needs to be renewed.  

Major aspects are:

  • Verification of correct operation of the new hardware and software according to vendor protocols
  • Specification measurements
  • Audit-ready documentation