Quartz PCI/CFR user interface showing the acquired NavCam image.
Quartz PCI/CFR user interface showing the acquired NavCam image.

Thermo Scientific Phenom Quartz PCI/CFR Software, available on all Phenom Desktop SEMs including the Thermo Scientific Phenom Pro, ProX, XL G2, and Pharos Desktop SEMs, helps you meet the requirements of 21 CFR Part 11. The integration of the Phenom Desktop SEM with the Quartz PCI/CFR Software allows direct acquisition of both navigational (optical) camera and SEM images. This significantly reduces the complexity of your standard operating procedures (SOPs), ensuring compliance with data integrity requirements.

After selecting the region of interest and the required imaging parameters in the Phenom user interface, you are able to acquire your images with the Quartz PCI/CFR Software.

Various post-acquisition image processing tools are available with Quartz PCI/CFR Software. These include brightness and contrast adjustments, local smoothing and sharpening tools, as well as annotation and drawing tools. Furthermore, sizes and distances are easily measured with a built-in tool.

All changes that are applied to your images are logged in an audit trail system that can be opened and viewed using Quartz PCI/CFR Software. Images can be signed electronically and PDF reports can be exported to finalize the analysis.

Note: Element identification and the Phenom ProSuite Software Package are not included in the Quartz PCI/CFR compliance solution.


Specifications

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Software solution providing 21 CFR Part 11 compliance for the Phenom Pro(X), Phenom XL and Phenom Pharos Desktop SEMs.
Compatible with all Thermo Scientific Phenom Desktop SEMs
Phenom workstation and monitor
Windows 10 64-bit operating system support
Direct image acquisition from the Phenom Desktop SEM:
  • Navigation camera image acquisition
  • Electron backscatter diffraction (EBSD) or secondary electron (SE) image acquisition
Configurable user rights and roles
User-specific audit trail
Electronic signatures
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