Driving XRD in Regulated Environments - XRDynamic 500 Supporting FDA Title 21 CFR Part 11
The XRDynamic 500 automated multipurpose powder X-ray diffractometer drives unbeatable XRD data quality with maximum efficiency. Enjoy the benefits of a versatile platform covering a wide variety of applications while ensuring compliance with FDA Title 21 CFR part 11 and ALCOA+ guidelines. Intuitive to use, with fully automated optics and alignment routines, it al-lows everyone, from novices to experts to collect top-quality and compliant XRD data quickly while minimizing errors.
Introduction
To be able to use a power X-ray diffractometer in regulated environments such as the pharmaceutical industry, the instrument has to fulfill several specific guidelines such as FDA Title 21 CFR Part 11 and ALCOA+. This report will provide an overview of the specific features provided by XRDynamic 500 to meet these requirements.
Software features in XRDdrive and XRDview
XRDynamic 500, the XRDdrive instrument control software, and the XRDview data visualization package, seamlessly combine straightforward instrument handling and intuitive workflows, thanks to intelligent system automation. Pharma-compliant software features, such as user management, audit trail, and electronic signature, ensure complete compliance and traceability, reducing the workload required to integrate XRDynamic 500 into your system.
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