PCI-CFR Reviews & Product Details

Quartz PCI-CFR is a specialized version of Quartz PCI built for laboratories that must manage digital microscope images in compliance with FDA 21 CFR Part 11 regulations governing electronic records and electronic signatures. It is designed for pharmaceutical, biotechnology, and medical device labs where digital images function as regulated records, not just working files. Unlike text documents, where comparing two versions reveals exactly what changed, it is generally not possible to tell what processing steps were applied between two versions of an image. PCI-CFR addresses this by capturing data directly from the microscope with no intervening save step, then recording every subsequent processing and annotation operation in a secure, tamper-evident audit trail. Every version of an image is retained, encrypted, and protected by a cryptographic digest, so raw data and all downstream edits remain permanently recoverable and verifiable. Access is controlled through four standard user roles, acquisition, read-only, read-write, and signing, so labs can separate who can capture data from who can approve it. Authorized users apply digital signatures directly to image records, with signature metadata (signer, timestamp, and meaning, such as review or approval) embedded permanently in the file. Signed data can be exported as digitally signed PDFs suitable for regulatory submission. Two add-ons extend compliance beyond images: the Secure Repository creates a controlled virtual drive for non-image files (spectra, spreadsheets, third-party analysis output) under the same version control and audit trail; the Virtual Printer Driver lets any Windows application "print" its output directly into a compliant, signable PCI-CFR record. Quartz Imaging also offers IQ/OQ (Installation Qualification/Operational Qualification) support, conducted remotely or on-site, to help labs formally validate the software as part of their compliance documentation. The current release is PCI-CFR Version 6, sold by subscription with ongoing technical support and updates included.