Quartz PCI/CFR : Helping You Comply with 21 CFR Part 11

Quartz PCI / CFR is a special version of Quartz PCI designed to aid in compliance with FDA's 21 CFR Part 11 regulations.

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.

Image Capture

Images are captured directly from light and electron microscopes. Packages are available for direct image transfer from Hitachi PC SEMs or slow scan capture from other SEMs. For light microscopes, images can be acquired from video or digital still cameras.

Retention of Original Data

Original data transferred from the instrument is saved by the system prior to any changes by the operator. Thereafter, each version of the data is also stored as changes are made. It is always possible to retrieve predecessor versions of the data.

All versions of each image are retained by the system. It is always possible to retrieve predecessor versions.

Audit Trail

Every user action is retained in an audit trail.

Data Encryption

All data is encrypted to make unauthorized changes virtually impossible while, at the same time, digital signature technology makes tampering easily detectable.

Digital Signatures

Data can be exported as digitally signed PDF files.

Clicky Web Analytics