{"id":16642,"date":"2026-07-06T16:29:12","date_gmt":"2026-07-06T14:29:12","guid":{"rendered":"https:\/\/q-finity.de\/glossar\/audit-trail-begriff\/"},"modified":"2026-07-19T21:04:14","modified_gmt":"2026-07-19T19:04:14","slug":"audit-trail","status":"publish","type":"encyclopedia","link":"https:\/\/q-finity.de\/en\/glossar\/audit-trail\/","title":{"rendered":"Audit Trail"},"content":{"rendered":"<p>An audit trail is the secure, computer-generated, time-stamped record of relevant creations, changes, and deletions of GxP-relevant data &ndash; who, what, when, and why; which events it captures is defined on a risk basis (<a href=\"https:\/\/q-finity.de\/en\/glossar\/eu-gmp-annex-11\/\" target=\"_self\" title='EU GMP Annex 11 (\"Computerised Systems\") is the European GMP annex for computerized systems: introduced in 1992, current in its 2011 version, part of EudraLex Vol. 4. Its principle divides the world of evidence in two: the application is validated, the IT infrastructure is qualified. Annex 11 requires a risk-based approach across the entire lifecycle&hellip;' class=\"encyclopedia\">EU GMP Annex 11<\/a> &sect;9; 21 CFR 11.10(e)). It makes changes reconstructable (Traceable) and is a regular focus of inspections.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>An audit trail is the secure, computer-generated, time-stamped record of relevant creations, changes, and deletions of GxP-relevant data &#8211; who, what, when, and why; which events it captures is defined on a risk basis (EU GMP Annex 11 \u00a79; 21 CFR 11.10(e)). It makes changes reconstructable (Traceable) and is a regular focus of inspections.<\/p>\n","protected":false},"author":3,"featured_media":0,"template":"","encyclopedia-tag":[],"class_list":["post-16642","encyclopedia","type-encyclopedia","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Audit Trail - Definition | QFINITY<\/title>\n<meta name=\"description\" content=\"Der Audit Trail zeichnet sicher und zeitgestempelt jede Erstellung, \u00c4nderung und L\u00f6schung GxP-relevanter Daten auf - wer, was, wann und warum.\" \/>\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\/audit-trail\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Audit Trail - Definition | QFINITY\" \/>\n<meta property=\"og:description\" content=\"Der Audit Trail zeichnet sicher und zeitgestempelt jede Erstellung, \u00c4nderung und L\u00f6schung GxP-relevanter Daten auf - wer, was, wann und warum.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/glossar\/audit-trail\/\" \/>\n<meta property=\"og:site_name\" content=\"QFINITY\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-19T19:04:14+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:title\" content=\"Audit Trail\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/glossar\\\/audit-trail\\\/\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/glossar\\\/audit-trail\\\/\",\"name\":\"Audit Trail - Definition | QFINITY\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#website\"},\"datePublished\":\"2026-07-06T14:29:12+00:00\",\"dateModified\":\"2026-07-19T19:04:14+00:00\",\"description\":\"Der Audit Trail zeichnet sicher und zeitgestempelt jede Erstellung, \u00c4nderung und L\u00f6schung GxP-relevanter Daten auf - wer, was, wann und warum.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/glossar\\\/audit-trail\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/q-finity.de\\\/en\\\/glossar\\\/audit-trail\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/glossar\\\/audit-trail\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/q-finity.de\\\/en\\\/home\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Glossar\",\"item\":\"https:\\\/\\\/q-finity.de\\\/en\\\/glossar\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Audit Trail\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/\",\"name\":\"QFINITY\",\"description\":\"Qualit\u00e4tsmanagement &amp; 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