{"id":68231,"date":"2023-01-19T10:00:44","date_gmt":"2023-01-19T09:00:44","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?post_type=resources&#038;p=68231"},"modified":"2026-03-23T12:03:53","modified_gmt":"2026-03-23T11:03:53","slug":"regulatory-inspection-day-checklist","status":"publish","type":"resources","link":"https:\/\/pantheon.veeva.com\/eu\/resources\/regulatory-inspection-day-checklist\/","title":{"rendered":"How to Successfully Navigate <br class=\"hidden-xs\"> the Day of a Regulatory Inspection"},"content":{"rendered":"<br \/>\n<style>\n  .fa-ul {\nlist-style-type: none;\nmargin-left: 28px;\npadding-left: 0;\n}\n  .fas.fa-check-square {\nfont-weight: normal;\nfont-size: 24px;\n}\n.resources-content at-a-glance {<\/p>\n<p>padding: 20px 20px 15px 20px;<\/p>\n<p>}\n.resources-content ul ul {\nmargin-bottom:15px;\n}\n<\/style>\n<p> <at-a-glance class=\"outline\"><\/p>\n<h4>RELATED READING<\/h4>\n<ul>\n<li><a id=\"cta-tmf-ins-pt1-top-pt3\" href=\"\/eu\/resources\/tmf-inspection-readiness-checklist\/\">Part 1: Build Compliance Culture<\/a><\/li>\n<li><a id=\"cta-tmf-ins-pt2-top-pt3\" href=\"\/eu\/resources\/regulatory-inspection-sop-checklist\/?\">Part 2: Prepare for Inspection<\/a><\/li>\n<li><strong>Part 3: Navigate Inspection Day<\/strong><\/li>\n<li><a  id=\"cta-tmf-trend-rpt-top-pt3\" href=\"\/eu\/tmf-trend-report-2025\/\">2025 TMF Trend Report<\/a><\/li>\n<\/ul>\n<p><\/at-a-glance><\/p>\n<p>\n<em> This is part three in a series of checklists to create and maintain an inspection-ready culture and prepare for a regulatory inspection.<br \/>\n<\/em>\n<\/p>\n<p>\nThe best preparation for a regulatory inspection starts with a strong culture of TMF inspection readiness and a well-documented SOP. With these in place, the following tips will help your organization successfully navigate the day of inspection.\n<\/p>\n<ul class=\"fa-ul\">\n<li style=\"display:inline-block\"><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span><br \/>\n<span style=\"font-size:20px;font-weight:400\">Obtain inspection information<\/span><\/p>\n<p>\nGet the inspector\u2019s full name, title, and contact information. Determine what will be inspected. Ask for the reason for the inspection, and the planned duration.\n<\/p>\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span><br \/>\n<span style=\"font-size:20px;font-weight:400\">Notify all stakeholders and affected personnel<br \/>\n<\/span><\/p>\n<p>\nAlert the team that preparation activities will take place and specify who should be involved.\n<\/p>\n<p>\nConsult the inspection preparation SOP and review training materials. Review your SOP to ensure documented procedures are followed. Check the training materials for accuracy and make any necessary changes.\n<\/p>\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span><br \/>\n<span style=\"font-size:20px;font-weight:400\">Review past inspection reports<\/span><\/p>\n<p>\nReview any significant observations and corresponding responses. Ensure that findings from past inspections were addressed and recorded. Be prepared to answer related questions.\n<\/p>\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span><br \/>\n<span style=\"font-size:20px;font-weight:400\">Remind your team (and yourself) to stay calm<\/span><\/p>\n<p>\nYou have done everything you could to ensure the best possible outcome. Remind everyone that they are ready for this!\n<\/p>\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span><br \/>\n<span style=\"font-size:20px;font-weight:400\">Welcome and brief the inspector<\/span><\/p>\n<p>\nMake sure the inspector\u2019s room is properly equipped with the necessary tools and\/or refreshments. If there is a welcome packet, make sure to show it to the inspector and inform them what it contains. Provide training on your TMF, but make sure that it lasts no longer than 15-20 minutes.\n<\/p>\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span><br \/>\n<span style=\"font-size:20px;font-weight:400\">Assign a liaison and escort for the inspector<\/span><\/p>\n<p>\nDesignate a point person or escort to field questions from the inspector or bring in applicable staff as needed. Although it is not necessary to chaperone the inspector at all times, inspectors should not be allowed to roam the site unattended.\n<\/p>\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span><br \/>\n<span style=\"font-size:20px;font-weight:400\">Ensure appropriate access for virtual inspections<\/span><\/p>\n<p>\nIf a component of your inspection is virtual, ensure that the inspector has the appropriate access to your eTMF, as well as ancillary tools such as video conferencing software and technical support.\n<\/p>\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span><br \/>\n<span style=\"font-size:20px;font-weight:400\">Answers questions concisely<\/span><\/p>\n<p>\nAll questions should be answered honestly and completely; do not volunteer information beyond the scope of the initial question.\n<\/p>\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span><br \/>\n<span style=\"font-size:20px;font-weight:400\">Keep a general log of daily inspection progress<\/span><\/p>\n<p>\nKeep a record of what was reviewed, the personnel involved, and any deviations noted by inspectors.\n<\/p>\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span><br \/>\n<span style=\"font-size:20px;font-weight:400\">Keep a record of requested documents<\/span><\/p>\n<p>\nIf digital copies of documents from an eTMF are provided to the inspector, a log of those files should be sufficient. If paper copies were provided, keep physical copies of the documents for your own records.\n<\/p>\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span><br \/>\n<span style=\"font-size:20px;font-weight:400\">Have a daily debrief with the inspector<\/span><\/p>\n<p>\nAsk the inspector to provide a summary of what they did that day, including any findings, and what is planned the next day. Provide a response to findings before the inspection ends (if possible). On the last day of the inspection, hold a final review meeting with the inspector.\n<\/p>\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span><br \/>\n<span style=\"font-size:20px;font-weight:400\">Alert team members when the inspection is over<\/span><\/p>\n<p>\nCongratulate them on their teamwork and completion of the inspection.\n<\/p>\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span><br \/>\n<span style=\"font-size:20px;font-weight:400\">Conduct a post-mortem<br \/>\n<\/span><\/p>\n<p>\nUse a post-mortem review to identify any mishaps that occurred during the inspection, and if possible, how to avoid them in the future. Update the inspection preparation SOP if necessary.\n<\/p>\n<\/ul>\n<hr>\n<p> <at-a-glance class=\"outline\"><\/p>\n<h4>RELATED READING<\/h4>\n<ul>\n<li><a id=\"cta-tmf-ins-pt1-btm-pt3\" href=\"\/eu\/resources\/tmf-inspection-readiness-checklist\/\">Part 1: Build Compliance Culture<\/a><\/li>\n<li><a id=\"cta-tmf-ins-pt2-btm-pt3\" href=\"\/eu\/resources\/regulatory-inspection-sop-checklist\/?\">Part 2: Prepare for Inspection<\/a><\/li>\n<li><strong>Part 3: Navigate Inspection Day<\/strong><\/li>\n<li><a id=\"cta-tmf-trend-rpt-btm-pt3\" href=\"\/eu\/tmf-trend-report-2025\/\">2025 TMF Trend Report<\/a><\/li>\n<\/ul>\n<p><\/at-a-glance><\/p>\n<p><em> This is part three in a series of checklists to create and maintain an inspection-ready culture and prepare for a regulatory inspection.<br \/>\n<\/em><\/p>\n<p>\n<em>Learn how a mid-sized biotechnology company <a href=\"\/eu\/resources\/the-four-pillars-of-inspection-readiness-and-success\/\">passed an FDA inspection<\/a> with only two days\u2019 notice in this white paper.<\/a><br \/>\n<\/em>\n<\/p>\n<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Learn how to help your organization successfully navigate the day of an inspection.<\/p>\n","protected":false},"featured_media":68228,"parent":0,"template":"","class_list":["post-68231","resources","type-resources","status-publish","has-post-thumbnail","hentry","resource-area-20-clinical-operations","resource-product-20-etmf","resource-type-articles"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/68231"}],"collection":[{"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/resources"}],"about":[{"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/types\/resources"}],"version-history":[{"count":2,"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/68231\/revisions"}],"predecessor-version":[{"id":68825,"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/68231\/revisions\/68825"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/media\/68228"}],"wp:attachment":[{"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=68231"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}