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Quartz PCI/21 CFR Part 11

A cryptographically signed PDF file after processing with the Phenom Scanning Electron Microscope

Quartz PCI/21 CFR Part 11

In order for a microscope to comply with the US Food and Drug Administration’s 21CFR Part 11 requirements for electronic record keeping, specialized software is required to audit every processing step and retain read-only copies of the old versions of images. The Quartz PCI/CFR software provided by Nanoscience Instruments can be purchased as an add-on for any Phenom SEM in order to help labs within the pharmaceutical industry maintain a compliant SEM for QA/QC purposes. We also assist quality labs with IQ/OQ on this SEM/Software combination.

When Quartz is operating, the acquisition of an image and all of the data processing that takes place afterward is recorded in a secure audit trail and all exported data is cryptographically signed to ensure tampering doesn’t occur.

Specifications

  • Secure audit trail.
  • User authentication required before software starts and after periods of inactivity.
  • Retains copies of all versions of data.
  • Use of encryption and digests to ensure data integrity.
  • Export digitally signed PDF files.
  • Includes several common image manipulation functions.
  • IQ/OQ available.