{"id":16821,"date":"2026-07-21T18:31:43","date_gmt":"2026-07-21T16:31:43","guid":{"rendered":"https:\/\/q-finity.de\/glossar\/predicate-rules\/"},"modified":"2026-08-19T19:47:58","modified_gmt":"2026-08-19T17:47:58","slug":"predicate-rules","status":"publish","type":"encyclopedia","link":"https:\/\/q-finity.de\/en\/glossar\/predicate-rules\/","title":{"rendered":"Predicate Rules"},"content":{"rendered":"<p>Predicate Rules are the FDA&rsquo;s actual requirements, such as 21 CFR 211 for pharmaceuticals or Part 820 (the <a href=\"https:\/\/q-finity.de\/en\/glossar\/qmsr\/\" target=\"_self\" title=\"The Quality Management System Regulation (QMSR) is the U.S. regulation of the quality management system for medical devices - 21 CFR Part 820, effective February 2, 2026. It replaces the previous Quality System Regulation by directly incorporating the requirements of ISO 13485:2016 - a QMS built on ISO 13485 thus fulfills the core of the&hellip;\" class=\"encyclopedia\">QMSR<\/a> since 2026) for medical devices. They determine which records must be kept and which signatures must be applied. 21 CFR Part 11 itself does not require any record or signature; it only governs the requirements for their electronic form. The term does not come from Part 11 but from the FDA guidances on it. The Scope and Application guidance of 2003 coined it and deliberately construed the scope narrowly: what no predicate rule requires does not become a Part 11 record. Anyone looking to justify record-keeping or signature obligations therefore looks to the requirements, not to Part 11.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Predicate Rules are the FDA&#8217;s actual requirements, such as 21 CFR 211 for pharmaceuticals or Part 820 (the QMSR since 2026) for medical devices. They determine which records must be kept and which signatures must be applied.<\/p>\n","protected":false},"author":3,"featured_media":0,"template":"","encyclopedia-tag":[],"class_list":["post-16821","encyclopedia","type-encyclopedia","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Predicate Rules &#187; QFINITY<\/title>\n<meta name=\"description\" content=\"Predicate rules are the FDA requirements (21 CFR 211, QMSR) that mandate records and signatures - Part 11 only governs their electronic form.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/q-finity.de\/en\/glossar\/predicate-rules\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Predicate Rules\" \/>\n<meta property=\"og:description\" content=\"Predicate rules are the FDA requirements (21 CFR 211, QMSR) that mandate records and signatures - Part 11 only governs their electronic form.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/glossar\/predicate-rules\/\" \/>\n<meta property=\"og:site_name\" content=\"QFINITY\" \/>\n<meta property=\"article:modified_time\" content=\"2026-08-19T17:47:58+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/glossar\\\/predicate-rules\\\/\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/glossar\\\/predicate-rules\\\/\",\"name\":\"Predicate Rules &#187; 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