Quartz PCI/CFR

Meeting the challenge of 21 CFR Part 11 compliance for microscopy

Maintaining CFR compliance for your digital images is challenging. Unlike text documents, where it is a simple matter to compare old and new versions to determine how they have been changed, it is usually not possible, when looking at two versions of an image, to determine the processing steps that have led to the changed image. Therefore, specialized software is required to audit every processing step and to keep read-only copies of every predecessor version of each image.

Whether you use light or electron microscopes, Quartz PCI/CFR helps you meet this challenge. PCI/CFR acquires data directly from the instrument with no intervening file save step. Therefore, you are assured that the original, raw data has been captured from the instrument. After data capture, every processing and annotation operation that is carried out on the image is recorded in a secure audit trail. The raw data and each subsequent version of the image are saved in read-only, encrypted files so that you can always retrieve earlier versions of processed images and you can be sure they have not been tampered with. Finally, you can export your data as digitally signed, industry standard PDF files for regulatory submission or sharing with colleagues.