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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Hassle Free
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All-in-One

Data Integrity and Instrument Qualification

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

GxP Readiness Kit NEO

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

 Benefits

  • Reduce the risk of not passing an inspection
  • Hassle-free and time saver:  it reduces effort and time required to achieve compliance, with on-site support being provided by a fully qualified service engineer. Minimal disruption to the operation of existing systems (typically <2 days)

Features

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

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
  • Windows OS at the spectrometer computer




Webinaires

More Information

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

 

Témoignages

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
 

Support

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