The purpose of this document is to describe how our instruments support XRD system owners to meet the 21 CFR Part 11 regulations as issued by the United States’ FDA.

Integration of our systems in a 21 CFR Part 11 compliant laboratory environment is straightforward. PANalytical offers tools and services to guarantee authenticity, integrity and confidentiality of electronic records and electronic signatures. 

As well as this, the final system qualification is supported with products and services. 

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