Compliance

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.

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
  
  

• 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