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QUARTZ PCI / CFR
21 CFR PART 11 COMPLIANCE FOR MICROSCOPES
Need to comply with 21 CFR Part 11?

You need Quartz PCI/CFR

FDA 21 CFR Part 11 Compliance for Microscopes

  • Audit trail on all operations
  • Creates new version with each save
  • Retains all versions
  • Data files are encrypted
  • Detects tampering efforts
  • Export to digitally signed PDF
  • IQ/OQ Available
  • Works with many types of microscopes

What’s New in PCI/CFR

  • Windows 10 support
  • 64 bit OS compatible
  • Digital signing within PCI/CFR (without Acrobat)
  • Can be set up to require user login (standard set up uses Windows login)
  • Different user rights and roles available (eg. Read only or Read/Write)
  • Virtual Printer Driver option for importation of non-image data, such as EDX spectra
  • Ability to lock down data storage, data retrieval and/or data export locations
  • Additional print options to include audit trail and digital signatures on print-out
  • Integration with Phenom and Zeiss electron microscopes (in addition to the Hitachi and Tescan integration offered in previous versions)
  • Support for reading calibration from JEOL electron microscope image formats
  • Support for reading calibration from Hitachi TM4000 image format
  • Support for images larger than 4096 x 4096
More Info Demo