ResourceSpectroscopy
XRD Systems - Supporting the Pharmaceutical Industry with 21 CFR Part 11 Compliance Readiness
26 Apr 2018This whitepaper describes how Malvern PANalytical systems support system owners meeting the requirements of the 21 CFR Part 11 regulations issued by the USA FDA. Malvern PANalytical offers tools and services to guarantee authenticity, integrity and confidentiality of electronic records and electronic signatures.
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X-Ray Diffraction and SpectroscopyX-Ray diffraction & spectroscopy are used in material characterization to discern the structure and elemental composition of a sample. X-Ray diffractometers (XRD) are superior instruments in elucidating the dimensional atomic structure of crystalline materials, including powders, thin films and single crystals. For large unit cells or ordered macromolecules, consider small-angle X-ray scattering (SAXS). X-ray spectroscopic techniques include X-ray fluorescence (XRF) and X-ray photoelectron spectroscopy (XPS), both providing simple and accurate methods for determining the elemental composition of a material. Energy dispersive (EDXRF) and wavelength dispersive (WDXRF) XRF spectrometers are available, as well as handheld/portable devices. High-resolution, 3D microstructure characterization of materials can be achieved with X-ray microscopes combining sub-micron resolution imaging with 3D computed tomography. Find the best XRD and XRF spectrometers in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. X-Ray FluorescenceX-ray fluorescence (XRF) is an analytical technique used to determine the elemental composition of materials. It is widely used in geology, materials science, and environmental testing for detecting heavy metals and other elements. Browse our peer-reviewed product directory to find the best XRF systems, compare products, check reviews, and get pricing directly from manufacturers.RegulatoryISO Certification