1. [Home](https://www.g2.com/) 2. ... 3. [Electronic Trial Master File (eTMF) Software](https://www.g2.com/categories/electronic-trial-master-file-etmf) 4. [PCI-CFR Discussions](https://www.g2.com/products/pci-cfr/discuss) [ ![Product Avatar Image](https://images.g2crowd.com/uploads/product/image/large_detail/large_detail_bf644c9ca59e35bd85ea7a625d48716b/pci-cfr.jpg "Product Avatar Image") ](/products/pci-cfr/reviews) [ PCI-CFR ](/products/pci-cfr/reviews) 0 ratings 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. Show More When users leave PCI-CFR reviews, G2 also collects common questions about the day-to-day use of PCI-CFR. These questions are then answered by our community of 850k professionals. Submit your question below and join in on the G2 Discussion. * * * ### 0.0 Nps Score ### All PCI-CFR Discussions Search Most CommentedMost HelpfulCommon QuestionsNewest All DiscussionsDiscussions with CommentsCommon QuestionsDiscussions without Comments FilterFilter Filter byExpand/Collapse Sort by Most Commented Most Helpful Common Questions Newest Filter by All Discussions Discussions with Comments Common Questions Discussions without Comments Sorry... There are no questions about PCI-CFR yet. ## Start a New Software Discussion Have a software question? Get answers from real users and experts [Start A Discussion](/products/pci-cfr/discussions/new) * * * ![Product Avatar Image](https://images.g2crowd.com/uploads/product/image/thumb_square/thumb_square_bf644c9ca59e35bd85ea7a625d48716b/pci-cfr.jpg "Product Avatar Image") ### Have you used PCI-CFR before? Answer a few questions to help the PCI-CFR community [ Yes ](javascript:void(0))[ Yes ](https://www.g2.com/login?context=product_review&return_to=https%3A%2F%2Fwww.g2.com%2Fproducts%2Fpci-cfr%2Fdiscuss%3Fsmall_ask%3Dpci-cfr) No