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.
New tools for Data Integrity (DI), compliance and good laboratory and manufacturing practices.
Successful commissioning of an NMR system for a GxP environment: details of a modern and efficient approach to achieving compliance
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
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