{"id":28398,"date":"2020-05-12T21:13:08","date_gmt":"2020-05-12T19:13:08","guid":{"rendered":"http:\/\/www.veeva.com\/eu\/?page_id=28398"},"modified":"2026-04-03T10:35:32","modified_gmt":"2026-04-03T08:35:32","slug":"tmf-inspection-readiness","status":"publish","type":"page","link":"https:\/\/www.veeva.com\/eu\/tmf-inspection-readiness\/","title":{"rendered":"Achieve an Ongoing State of TMF Inspection Readiness"},"content":{"rendered":"<section>\n<section class=\"block\">\n<div class=\"product-banner-hero\" style=\"background-image: url('https:\/\/www.veeva.com\/wp-content\/uploads\/2022\/04\/Inspection-Readiness-Hero.png');\">\n<div class=\"container\">\n<div class=\"row\">\n<div class=\"col-xs-12\">\n<div class=\"breadcrumbs\">\n\t\t\t\t\t\t<a href=\"\/eu\/\">Home<\/a> \u00b7 Inspection Readiness\n\t\t\t\t\t<\/div>\n<\/p><\/div>\n<\/p><\/div>\n<div class=\"row table-row\">\n<div class=\"col-xs-12\">\n<h2>Achieve an Ongoing<br class=\"hidden-lg\"> State<br class=\"hidden-xs hidden-sm hidden-md\"> of TMF<br class=\"hidden-lg\"> Inspection Readiness<\/h2>\n<p>\n\t\t\t\t\tTMF best practices to help you prepare<br class=\"hidden-xs\"> and maintain TMF inspection readiness.\n\t\t\t\t\t<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<div class=\"product-container\" style=\"background-color:#fff;\">\n<div class=\"container\">\n<div class=\"row\">\n<div class=\"col-sm-10 col-sm-offset-1\">\n<h1>Is Your TMF Inspection Ready?<\/h1>\n<p>\n\t\t\t\t\tMHRA reported an 11% increase in critical TMF findings because of incomplete or inaccessible trial master files. How can you get TMF inspection ready and avoid inspection delays? We&#8217;ve prepared these resources to share TMF best practices and guidance from industry experts.\n\t\t\t\t<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<style>\n.modernizing a.title {\n\tfont-size:16px;\n\tfont-weight:500;\n\tline-height:24px;\n\tdisplay:block;\n}\n@media (max-width: 991px) {\n.modernizing .title br {\n\tdisplay:none;\n}\n}\n<\/style>\n<style>\n.inspection-box {\nwidth:100%;padding-top:30px;height:390px;margin-top:15px;font-size:24px;line-height:32px;\n}\n.inspection-box.green {\nbackground-color:#00b6b8;\n}\n.inspection-box.orange {\nbackground-color:#f89921;\n}\n.inspection-box.blue {\nbackground-color:#449fd8;\n}\n.inspection-box  .number {\n\tfont-size:70px;font-weight:400;\n\tcolor:#fff;\n\tmargin-top:35px;\n\tmargin-bottom:60px;\n\topacity: 0.5;\n}\n.inspection-box .text {\nfont-weight:400;color:#182f53;padding-bottom:40px;\n}\n.inspection-box a {\ncolor:#fff;font-weight:500;font-size:18px;\n}\n.inspection-box a:hover {\n  color: #fff;\n  text-shadow: 0px 0px 7px rgba(255,255,255,.5);\n}<\/p>\n<p>@media (max-width: 767px) {\n\t.inspection-box {\n\t\twidth:100%;padding-top:30px;height:auto;margin-top:15px;padding-bottom:30px;font-size:20px;line-height:26px;\n\t}\n\t.inspection-box  .number {\n\t\tfont-size:60px;font-weight:400;\n\t\tcolor:#fff;\n\t\tmargin-top:0;\n\t\tmargin-bottom:20px;\n\t}\n}<\/p>\n<p>.inspection-box2 {\n\twidth:100%;\n\tpadding:0;\n\tmargin:0;\n\ttext-align:left;\n}\n.inspection-box2.green {\n\tbackground-color:#00b6b8;\n}\n.inspection-box2.orange {\n\tbackground-color:#f89921;\n}\n.inspection-box2.blue {\n\tbackground-color:#449fd8;\n}\n.inspection-box2 .number {\n\tfont-size:60px;\n\tfont-weight:400;\n\tcolor:#00b6b8;\n\tmargin-top:25px;\n}\n.inspection-box2 .text {\n\tfont-weight:500;\n\tcolor:#182f53;\n\tmargin-bottom:5px;\n}\n.inspection-box2 a {\n\tfont-weight:500;\n\tfont-size:18px;\n}<\/p>\n<p>@media (max-width: 767px) {\n\t.inspection-box2 {\n\t\twidth:100%;\n\t\tpadding-top:30px;\n\t\theight:auto;\n\t\tpadding-bottom:30px;\n\t\ttext-align:center;\n\t}\n\t.inspection-box2 .number {\n\t\tmargin-top:0;\n\t\tmargin-bottom:40px;\n\t}\n}\n<\/style>\n<section id=\"getting-ready\">\n<div class=\"product-container\" style=\"background-color:#fff;\">\n<div class=\"container\">\n<div class=\"row\">\n<div class=\"col-md-8 col-md-offset-2\">\n<h2>Getting Ready for TMF Inspection<\/h2>\n<p>\n\t\t\t\tUse this series of checklists to help your organization prepare for a successful regulatory inspection.\n\t\t\t\t<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<div class=\"row\">\n<div class=\"col-sm-12\">\n<div style=\"margin-top:30px\">\n<div class=\"row direction\">\n<div class=\"col-sm-6 equal-boxes\">\n<div class=\"shadow-box getting-ready\">\n<div class=\"row inspection-box2\">\n<div class=\"col-sm-2 text-center\">\n<p class=\"number\">1<\/p>\n<\/p><\/div>\n<div class=\"col-sm-10\">\n<div class=\"text\">\n\t\t\t\t\t\t\t\t\t\t\t\tTMF inspection readiness:<br \/>\n\t\t\t\t\t\t\t\t\t\t\t\tHow to create and maintain<br \/>\n\t\t\t\t\t\t\t\t\t\t\t\tan inspection-ready culture\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n<p>\t\t\t\t\t\t\t\t\t\t\t<a href=\"\/eu\/resources\/tmf-inspection-readiness-checklist\/\" class=\"after-arrow-orange\">Download<\/a>\n\t\t\t\t\t\t\t\t\t\t<\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<div class=\"col-sm-6 equal-boxes\">\n<div class=\"shadow-box getting-ready\">\n<div class=\"row inspection-box2\">\n<div class=\"col-sm-2 text-center\">\n<div class=\"number\">2<\/div>\n<\/p><\/div>\n<div class=\"col-sm-10\">\n<div class=\"text\">\n\t\t\t\t\t\t\t\t\t\t\t\tRegulatory inspection SOP:<br \/>\n\t\t\t\t\t\t\t\t\t\t\t\tHow to prepare for<br class=\"visible-sm\"><br \/>\n\t\t\t\t\t\t\t\t\t\t\t\tan inspection\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n<p>\t\t\t\t\t\t\t\t\t\t\t<a href=\"\/eu\/resources\/regulatory-inspection-sop-checklist\/\" class=\"after-arrow-orange\">Download<\/a>\n\t\t\t\t\t\t\t\t\t\t<\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<div class=\"row direction\">\n<div class=\"col-sm-6 equal-boxes\">\n<div class=\"shadow-box getting-ready\">\n<div class=\"row inspection-box2\">\n<div class=\"col-sm-2 text-center\">\n<div class=\"number\">3<\/div>\n<\/p><\/div>\n<div class=\"col-sm-10\">\n<div class=\"text\">\n\t\t\t\t\t\t\t\t\t\t\t\tRegulatory inspection day:<br \/>\n\t\t\t\t\t\t\t\t\t\t\t\tHow to successfully navigate<br \/>\n\t\t\t\t\t\t\t\t\t\t\t\ta regulatory inspection\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n<p>\t\t\t\t\t\t\t\t\t\t\t<a href=\"\/eu\/resources\/regulatory-inspection-day-checklist\/\" class=\"after-arrow-orange\">Download<\/a>\n\t\t\t\t\t\t\t\t\t\t<\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<div class=\"col-sm-6 equal-boxes\">\n<div class=\"shadow-box getting-ready\">\n<div class=\"row inspection-box2\">\n<div class=\"col-sm-2 text-center\">\n<div class=\"number\">4<\/div>\n<\/p><\/div>\n<div class=\"col-sm-10\">\n<div class=\"text\">\n\t\t\t\t\t\t\t\t\t\t\t\tRegulatory inspection takeaways: Biotech shares lessons learned from a successful inspection\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n<p>\t\t\t\t\t\t\t\t\t\t\t<a href=\"\/eu\/resources\/the-four-pillars-of-inspection-readiness-and-success\/\" class=\"after-arrow-orange\">Download<\/a>\n\t\t\t\t\t\t\t\t\t\t<\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<style>\n.shadow-box.getting-ready {\n\tpadding:20px;\n\tmargin-bottom:0;\n\ttext-align: left;\n\theight:100%;\n}<\/p>\n<p>.equal-boxes {\n\tmargin-bottom:20px;\n}<\/p>\n<p>.direction {\n\tdisplay:inline-flex;\n\tflex-direction:row;\n}<\/p>\n<p>@media (max-width: 767px) {\n\t.direction {\n\t\tdisplay:block;\n\t}\n}<\/p>\n<p>.comm-icons p {\nfont-size:14px;line-height:19px;margin-top:15px;\n}\n.comm-icons a {\ncolor:#666;\n}\n<\/style>\n<\/p><\/div>\n<\/div>\n<div class=\"product-container\" style=\"background-color:#f4f4f4;\">\n<div class=\"container\">\n<div class=\"row\">\n<div class=\"col-sm-12\">\n<div class=\"shadow-box\" style=\"margin-top:30px\">\n<div class=\"row\">\n<div class=\"col-md-12 text-center\">\n<h2>Industry Best Practice<\/h2>\n<p>\n\t\t\t\t\t\t\tLearn how your peers use active TMF management to achieve TMF inspection readiness.\n\t\t\t\t\t\t\t<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<div class=\"row comm-icons\" style=\"margin-top:30px\">\n<div class=\"col-sm-4 col-md-5ths text-center\">\n\t\t\t\t\t\t\t<img decoding=\"async\" src=\"\/wp-content\/uploads\/2026\/04\/Customer-Logo-OM-Pharma-180x65px.png\" alt=\"LOGO OM Pharma\"><\/p>\n<p>\n\t\t\t\t\t\t\t\t<a href=\"\/eu\/customer-stories\/om-pharma-drives-tmf-inspection-readiness\/\" target=\"_blank\" rel=\"noopener\">Drives TMF inspection readiness with a lean team<\/a>\n\t\t\t\t\t\t\t<\/p>\n<\/p><\/div>\n<div class=\"col-sm-4 col-md-5ths text-center\">\n\t\t\t\t\t\t\t<img decoding=\"async\" src=\"\/wp-content\/uploads\/2026\/04\/Customer-Logo-ImmunityBio-180x65px.png\" alt=\"LOGO ImmunityBio\"><\/p>\n<p>\n\t\t\t\t\t\t\t\t<a href=\"\/eu\/customer-stories\/unifying-clinical-operations-to-simplify-inspection-readiness\/\">Unifying clinical operations to simplify inspection readiness<\/a>\n\t\t\t\t\t\t\t<\/p>\n<\/p><\/div>\n<div class=\"col-sm-4 col-md-5ths text-center\">\n\t\t\t\t\t\t\t<img decoding=\"async\" src=\"\/eu\/wp-content\/themes\/veeva2015\/assets\/img\/global\/LOGO MERCK.png\" height=\"65\" alt=\"LOGO MERCK\"><\/p>\n<p>\n\t\t\t\t\t\t\t\t<a href=\"\/eu\/customer-stories\/eight-million-documents-and-5000-users-in-11-months\/\">Transforms trial efficiency with strategic eTMF initiative<\/a>\n\t\t\t\t\t\t\t<\/p>\n<\/p><\/div>\n<div class=\"col-sm-4 col-sm-offset-2 col-md-5ths col-md-offset-0 text-center\">\n\t\t\t\t\t\t\t<img decoding=\"async\" src=\"\/eu\/wp-content\/themes\/veeva2015\/assets\/img\/global\/LOGO ADVANCED CLINICAL.png\" height=\"65\" alt=\"LOGO ADVANCED CLINICAL\"><\/p>\n<p>\n\t\t\t\t\t\t\t\t<a href=\"\/eu\/customer-stories\/advanced-clinical-achieves-a-strategic-advantage-with-veeva-vault-etmf\/\">Leverages Veeva eTMF to run faster trials<\/a>\n\t\t\t\t\t\t\t<\/p>\n<\/p><\/div>\n<div class=\"col-sm-4 col-md-5ths text-center\">\n\t\t\t\t\t\t\t<img decoding=\"async\" src=\"\/eu\/wp-content\/themes\/veeva2015\/assets\/img\/global\/LOGO ALLAKOS.png\" height=\"65\" alt=\"LOGO ALLAKOS\"><\/p>\n<p>\n\t\t\t\t\t\t\t\t<a href=\"\/eu\/customer-stories\/choosing-veeva-vault-etmf\/\">Improves visibility into the activities of the study<\/a>\n\t\t\t\t\t\t\t<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<div class=\"row\">\n<div class=\"col-sm-12 text-center\">\n\t\t\t\t\t\t\t<a href=\"\/eu\/customers\/\" class=\"buttons orange\">More Success Stories<\/a>\n\t\t\t\t\t\t<\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<\/section>\n<style>\n.faqs-section img {\n    padding-top: 30px;\n}<\/p>\n<p>.faqs .panel-title > a:after {\n    font-family: 'Glyphicons Halflings';\n    content:\"\\f106\";\n    font-size:36px;\n    margin-right:5px;\n    color:#f5961d;\n    font-family: \"FontAwesome\"\n}\n.faqs .panel-title > a.collapsed:after {\n   \tcontent: \"\\f107\";\n}\n.faqs .panel-title > a {\n    font-size: 18px;\n    font-weight:500;\n    display: flex;\n    justify-content: space-between;\n}\n.faqs .panel-title > a.collapsed{\n   \tcontent: \"\\f107\";\n   \tfont-weight:500;\n   \twidth:100%;\n}\n.faqs .panel-title a.collapsed h2 {\n  color: inherit;\n}\n.faqs .panel-title a h2 {\n  color: #f5961d;\n  margin-bottom: 8px;\n}\n.faqs .panel-title > a.collapsed:hover,\n.panel-title > a h2:hover {\n   \tcolor:#f5961d;\n}<\/p>\n<p>.faqs .faq-text {\n  margin-top: 30px;\n  font-size: 18px;\n}\n.faqs{\n\tmargin:10px 0 30px 0;\n}\n.mb-0 p {\n  margin-bottom: 0;\n}\n@media screen and (max-width: 767px) {\n  .mb-mt-20 {\n    margin-top: 20px;\n  }\n  .faqs .faq-text {\n    font-size: 16px;\n    line-height: 23px;\n  }\n}\n<\/style>\n<p><!-- FAQs START --><\/p>\n<div class=\"product-container\">\n<div class=\"container\">\n<div class=\"row\">\n<div class=\"col-md-12\">\n<h2 class=\"fake-h1\">Frequently Asked Questions<\/h2>\n<p class=\"mb-30 hidden\">Here\u2019s a list of frequently asked questions that you can use to learn more about TMF Bot and how to enable it.<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<p>    <!-- START --><\/p>\n<div class=\"row text-left faqs-section\">\n      <!-- \n\n<div class=\"col-xs-12 col-sm-2 col-md-1 hidden-xs\">\n        <img decoding=\"async\" src=\"\/wp-content\/uploads\/2021\/09\/TMF-Bot-What-is-icon.png\" alt=\"TMF Bot What is icon\" class=\"img-responsive\">\n      <\/div>\n\n --><\/p>\n<div class=\"col-xs-12 col-sm-12 col-md-12\">\n<div class=\"faqs\">\n<div class=\"panel-title\">\n            <a class=\"collapsed\" data-toggle=\"collapse\" href=\"#what-is-faq1\"><\/p>\n<h2>What is inspection readiness?<\/h2>\n<p>            <\/a>\n          <\/div>\n<div id=\"what-is-faq1\" class=\"panel-collapse collapse\">\n<div class=\"faq-text\">\n\t\t\t\tInspection readiness means that your trial master file is adequately prepared for an official review by regulatory authorities. With proper planning and the right technology, your organization can achieve a constant state of inspection readiness. <a href=\"\/eu\/resources\/tmf-inspection-readiness-checklist\/\">Access this checklist for tips<\/a> to get started.\n            <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<hr><\/div>\n<\/p><\/div>\n<p>    <!-- END --><br \/>\n\t<!-- START --><\/p>\n<div class=\"row text-left faqs-section\">\n      <!-- \n\n<div class=\"col-xs-12 col-sm-2 col-md-1 hidden-xs\">\n        <img decoding=\"async\" src=\"\/wp-content\/uploads\/2021\/09\/TMF-Bot-What-is-icon.png\" alt=\"TMF Bot What is icon\" class=\"img-responsive\">\n      <\/div>\n\n --><\/p>\n<div class=\"col-xs-12 col-sm-12 col-md-12\">\n<div class=\"faqs\">\n<div class=\"panel-title\">\n            <a class=\"collapsed\" data-toggle=\"collapse\" href=\"#what-is-faq2\"><\/p>\n<h2>Is a TMF plan required?<\/h2>\n<p>            <\/a>\n          <\/div>\n<div id=\"what-is-faq2\" class=\"panel-collapse collapse\">\n<div class=\"faq-text\">\n\t\t\t\tA TMF plan is not required, but it is an important way to define the roles and responsibilities of all stakeholders across a study and document content requirements, inspection instructions, and quality check procedures. <a href=\"\/eu\/resources\/the-four-pillars-of-inspection-readiness-and-success\/\">Read how a biotechnology company aligned<\/a> business processes, documentation, and tools \u2014 and ultimately passed an FDA inspection with only two days&#8217; notice.\n            <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<hr><\/div>\n<\/p><\/div>\n<p>    <!-- END --><br \/>\n\t<!-- START --><\/p>\n<div class=\"row text-left faqs-section\">\n      <!-- \n\n<div class=\"col-xs-12 col-sm-2 col-md-1 hidden-xs\">\n        <img decoding=\"async\" src=\"\/wp-content\/uploads\/2021\/09\/TMF-Bot-What-is-icon.png\" alt=\"TMF Bot What is icon\" class=\"img-responsive\">\n      <\/div>\n\n --><\/p>\n<div class=\"col-xs-12 col-sm-12 col-md-12\">\n<div class=\"faqs\">\n<div class=\"panel-title\">\n            <a class=\"collapsed\" data-toggle=\"collapse\" href=\"#what-is-faq3\"><\/p>\n<h2>What are TMF inspection best practices?<\/h2>\n<p>            <\/a>\n          <\/div>\n<div id=\"what-is-faq3\" class=\"panel-collapse collapse\">\n<div class=\"faq-text\">\n\t\t\t\tIt is critical to create and maintain an inspection-ready culture with an active TMF operating model, meaning that study teams manage documents in real-time and apply quality control checks throughout a study. Access the best practice guides on this page for detailed information and checklists your organization can use to create this culture and successfully navigate a regulatory inspection.\n            <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<hr><\/div>\n<\/p><\/div>\n<p>    <!-- END -->\n  <\/div>\n<\/div>\n<\/section>\n","protected":false},"excerpt":{"rendered":"<p>TMF best practices to help you prepare and maintain TMF inspection readiness.<\/p>\n","protected":false},"author":42,"featured_media":61491,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/template-full-page.php","meta":{"footnotes":""},"coauthors":[1699],"class_list":["post-28398","page","type-page","status-publish","has-post-thumbnail","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/pages\/28398"}],"collection":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/users\/42"}],"replies":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/comments?post=28398"}],"version-history":[{"count":13,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/pages\/28398\/revisions"}],"predecessor-version":[{"id":96041,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/pages\/28398\/revisions\/96041"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/61491"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=28398"}],"wp:term":[{"taxonomy":"author","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/coauthors?post=28398"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}