Instrument Qualification

Instrument Qualification

Adherence to GxP compliance is mandatory when working in regulated environments, and instrument qualification in an important requirement. Bruker's well-established software tools for testing instrument performance have been augmented to support the whole qualification process using one set of documents.

User Benefits

  • Time savings for QA users, as the integrated package reduces effort and time-requirements, with on-site support being provided by a qualified service engineer.
  • Minimal disruption to the operation of existing systems (typically < 2 days)
  • All-in-one validation package, including IQ/OQ protocol and computer system validation protocol, as well as supporting certificates in one set of documents.
  • Package is applicable to new and existing systems.

Compatibility

Available for all Bruker high resolution NMR systems (All existing magnets) with TopSpin 3.5pl7 and above. IQ/OQ also available for minispec systems (TD-NMR).