Instrument Qualification

Instrument Qualification and Data Integrity

Adherence to the principles of instrument calibration, validation and data integrity (DI) is mandatory when working in regulatory environments, the prime example of which are the pharmaceuticals and biopharmaceuticals sectors. NMR is an established method for use in pharmaceutical manufacture, including product release as shown, for example, by the fact that there are multiple pharmacopoeial methods defined in the USP.

Bruker's software and other services are able to support end users in a numbers of ways, especially with calibration, qualification and general data integrity support:

Instrument Qualification

A GxP Readiness Kit is available and this includes an integrated suite of qualification protocols, together with associated documents that are available to support IQ/OQ and also Computer System Validation (CSV). Additionally, software to support PQ is also available. User Benefits include:

  • It is saves time, as the integrated package reduces effort and time requirements to completion, with on-site support being provided by a fully qualified service engineer
  • Minimal disruption to the operation of existing systems (typically <2 days)

Compatibility:

  • Available for all Bruker high resolution systems (All existing magnets) running Topspin 3.5pl7 and above
  • The readiness kit is applicable to new and existing systems (e.g. to support requests arising from change control)
  • IQ and OQ protocols are also available for minispec systems (TD-NMR)