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Certification and Validation
Good Laboratory Practice
Bruker has taken a lead in supporting those customers involved in GLP measures by researching the requirements for laboratories to introduce and maintain GLP with regard to their instrumentation, and has developed an inspection and certification package designed to comply with the principles of GLP.
As GLP requirements evolve, we will continue to update our inspection and certification package so that the instrumentation is always performing to the required standard.
Validation
Bruker can also offer, where applicable, compliance with the pharmaceutical industries stringent validation and regulatory requirements (21 CFR Part 11 compliance, USP 1119 compliance, IQ/OQ/PQ, GMP compliance, etc).
System Annual Inspection and Report
An annual inspection of a complete spectrometer system to check the main performance specifications, repair any deficiencies affecting performance or safety and provide a written report of the instrument status. This may be included in many Standard and Comprehensive Maintenance Contracts.
Certificate of Inspection
Following each annual inspection, provided the System Annual Inspection Report is satisfactory, a Certificate of Inspection is supplied to verify that the system has been examined/maintained and that its condition is suitable for GLP requirements.