Compliance

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.

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