NMR & EPR Pharma Solutions

Compliance

GxP enabling kit with new software tools specially designed for state-of-the-art data integrity and compliance according to 21 CFR, part 11 principles.

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Data Integrity and Instrument Qualification

NMR is an established analytical method used by pharmaceutical companies world-wide, with a growing proportion of instrumentation being operated in GLP and GMP environments. Applications range from raw material acceptance, through to product release to market. A comprehensive application note detailing such applications has been co-authored with Almac and is available to download below, under "More Information". Adherence to the principles of data integrity (DI) and instrument qualification is mandatory for such instrumentation and are hot topics for the regulatory authorities who actively look for DI issues when conducting inspections and reviews. In response to this, and based on customers’ feedback, Bruker has developed innovative GxP readiness tools for state-of-the-art compliance.

New GxP Readiness Kit

Web- and cloud-based, the new GxP Readiness Kit enables management of multiple instruments and spectroscopies in a validated environment. Based on an innovative DI framework, it aligns with the very best industrial practices and integrates with a whole range of user-defined workflows.

 Benefits

  • Reduces the risk of failing an inspection
  • Hassle-free and time saving: it reduces the effort and time required to achieve compliance, with on-site support provided by a fully qualified service engineer and minimal disruption to existing operation systems (typically less than 2 days)

Features

  • Log in and out without compromise and with full traceability
  • Structured around a database, instead of flat files
  • Users management with extensive role granularity
  • Method oriented and approval workflowes

Components

  • IQ & OQ protocols
  • PQ supportive software (systems suitability)
  • Certified samples
  • Enterprise software platform designed for state-of-the-art 21 CFR, part 11 compliance
  • Computer system validation protocol
  • 21 CFR, part 11 manual
  • Validation and GAMP certificates
  • Installation and training by GxP-qualified engineers

Compatibility

  • Spectrometers with AVANCE NEO console, equipped with either liquids or solid probes
  • Fourier 80 spectrometers




 

 

Webinars

More Information

New tools for Data Integrity (DI), compliance and good laboratory and manufacturing practices.

 

Testimonios

Testimonial

Successful commissioning of an NMR system for a GxP environment:  details of a modern and efficient approach to achieving compliance

White Papers

Whenever data is generated, processed and analysed, it is important that it is done in a manner that is consistent with the principles of data integrity (DI) so that the data, together with any conclusions drawn from it can be used with confidence.

NMR under GxP in Drug Development and Manufacturing  

qPQ Quantitative Performance Qualification test  and certified reference standard and
 

Más información

More Information

  • Successful commissioning of an NMR system for a GxP environment: details of a modern and efficient approach to achieving compliance
  • Data Integrity in the Pharmaceutical Industry How Bruker BioSpin can help
  • NMR under GxP in Drug Development and Manufacturing
  • nmr-pharma-qPQ_apps.pdf
  • NMR in Pharma Instrument Qualification.pdf
  • NMR in Pharma The Principles of Change Control.pdf
  • NMR in Pharma Application of Data Integrity Principles.pdf

Soporte

Labscape

Service & Life Cycle Support for Magnetic Resonance and Preclinical Imaging

Bruker’s commitment to provide customers with unparalleled help throughout the buying cycle, from initial inquiry to evaluation, installation, and the lifetime of the instrument is now characterized by the LabScape service concept.

LabScape Maintenance Agreements, On-Site On-Demand and Enhance Your Lab are designed to offer a new approach to maintenance and service for the modern laboratory