Federal Register Part VIII Department of Health and Human Services Food and Drug Administration 21 CFR Part 1271Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement; Proposed Rule

This CBER proposed rulefor Cell and tissue banks mentions computer system validation in several places. The link provided has a version of the rule with our highlights on references to computer system validation including pages 1513, 1529 and 1530. Page 1530 has some interesting assumptions regarding validation and cost. It assumes that there is no cost for validation of off-the-shelf software since the vendor will have validated it and estimates 60 hours of work for a lab supervisor to validate custom software.