{"id":7695,"date":"2014-04-28T03:11:44","date_gmt":"2014-04-28T01:11:44","guid":{"rendered":"http:\/\/eu.veeva.com\/?post_type=resources&#038;p=7695"},"modified":"2025-11-25T16:18:32","modified_gmt":"2025-11-25T15:18:32","slug":"veeva-etmf-product-brief","status":"publish","type":"resources","link":"https:\/\/www.veeva.com\/eu\/resources\/veeva-etmf-product-brief\/","title":{"rendered":"Veeva eTMF Features Brief"},"content":{"rendered":"<style>\n.veeva-2024 .fa-ul li p {\n  margin-top: 5px;\n}\n.veeva-2024 .content-block .fa-check-circle {\n  color: #f7981d;\n  font-weight: 400;\n  font-size: 20px;\n}\n@media (min-width: 768px) {\n  .veeva-2024 .hero-centered {\n    padding: 100px 0;\n  }\n}\n@media (min-width: 992px) {\n  .veeva-2024 .content-block {\n    margin-top: 6rem;\n  }\n}\n.veeva-2024 .content-block__sidebar {\n  display: none;\n}\n<\/style>\n<p><img decoding=\"async\" class=\"img-right d-none d-lg-block\" alt=\"\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2025\/10\/Veeva-eTMF-FB-Img-1.png\"><\/p>\n<h2>Efficient, Inspection-Ready TMF Management<\/h2>\n<p>\nVeeva eTMF provides real-time inspection readiness, full visibility into TMF status, and access for all study partners. Sponsors get the clarity they need to oversee trials more effectively. CROs gain the flexibility<br \/>\nand control required to operationalize their SOPs and efficiently populate the eTMF. Auditors get easy online access with a dedicated role.<\/p>\n<p>Veeva eTMF promotes the highest levels of TMF quality, access, visibility, and control.<\/p>\n<h3 style=\"color:orange\">Business Benefits<\/h3>\n<ul class=\"fa-ul\">\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Real-time inspection readiness<\/strong> <br \/>\nBusiness-specific workflows ensure TMF content gets managed in real-time, enabling accurate reporting and better decision-making. Organizations can feel confident that their TMFs are complete at all times, eliminating the need for rework at the end of a study.<\/li>\n<\/p>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Streamline collaboration<\/strong> <br \/>\nGive study teams a real-time view of TMF completeness to help sponsors, CROs, and sites work together to<br \/>\naccelerate trials.<\/li>\n<\/p>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Unify clinical operations<\/strong> <br \/>\nSpeed trial execution by leveraging the most comprehensive group of clinical applications on a single cloud platform.<\/li>\n<\/p>\n<\/ul>\n<h3>Active TMF<\/h3>\n<p>Active TMF management ensures all TMF documents, related information, and processes are managed in the same<br \/>\nsystem, in real-time, as they are being executed. As a result, TMF management is automated and in a constant state of inspection readiness.<\/p>\n<p>\nThe entire document lifecycle can be tracked, providing access to a greater set of metrics and data to inform business decisions. Challenges and bottlenecks can be corrected during the course of the study, and manual rework at the end is eliminated.<\/p>\n<p>\nWith an active TMF, adherence to study SOPs and regulatory requirements are not afterthoughts but instead part of an ongoing process to ensure your TMF is always inspection-ready. Veeva eTMF is the only electronic trial master file that enables an active TMF operating model.\n<\/p>\n<ul class=\"fa-ul\">\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>TMF Reference Model support<\/strong> <br \/>\nVeeva eTMF supports the TMF Reference Model for the documents, properties, relationships, and hierarchies for both core and recommended documents.\n<\/li>\n<\/p>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Risk-based document QC<\/strong> <br \/>\nStreamline quality checks by assigning risk levels to document types and setting sampling percentages for each level. The system automatically assesses documents to determine if a QC is needed, focusing on the most critical content while supporting traceability for the audit trail.\n<\/li>\n<\/p>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>TMF Transfer<\/strong> <br \/>\nEnable study teams to quickly and accurately transfer TMF documents without manual end-of-study migrations.<br \/>\nWith a single click, completed study country, study site, associated TMF documents, and audit trail information are seamlessly transferred between sponsor and CRO.\n<\/li>\n<\/p>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>TMF Homepage<\/strong> <br \/>\nGet a high-level overview of your TMF milestones and completeness with the TMF Homepage. Use real-time<br \/>\ndashboards and reports to answer questions about progress and completeness, make proactive decisions, and remedy process bottlenecks.\n<\/li>\n<\/p>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Completeness reporting<\/strong> <br \/>\nIdentify the documents that need to be collected for a given study with the Expected Document List (EDL). This<br \/>\nfunctionality empowers users to identify missing documents and take action to upload files directly via drag and drop.\n<\/li>\n<\/p>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Real-time collaborative authoring<\/strong> <br \/>\nSupport real-time collaborative authoring on all clinical documents in a compliant way with a seamless integration between Veeva and Microsoft Office Online.\n<\/li>\n<\/p>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>TMF Viewer<\/strong> <br \/>\nSearch and access all document versions, as well as export data to Microsoft Excel, with the TMF Viewer. It<br \/>\nprovides a real-time view of documents during a study and a full historical picture after study completion.\n<\/li>\n<\/p>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Document quality check workflow<\/strong> <br \/>\nInitiate quality checks at the appropriate time to improve accuracy on an ongoing<br \/>\nbasis. Users can review document content and metadata simultaneously for each document, making the process<br \/>\neasier and more efficient.\n<\/li>\n<\/p>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Global Health Authority submission support<\/strong> <br \/>\nVeeva eTMF automatically creates submission-ready files and captures details relevant for submissions<br \/>\nprocessing. This eliminates significant downstream processing and removes unnecessary time and expense.\n<\/li>\n<\/p>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Timeliness tracking<\/strong> <br \/>\nCalculate the amount of time it takes between two different actions, such as document creation date and document approval date. Timeliness metrics show how quickly departments and partners get documents into your TMF and enable you to review and act on areas of concern.\n<\/li>\n<\/p>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Connectivity with LMS<\/strong> <br \/>\nSimplify and automate training and reconciliation with the seamless connection between Veeva eTMF and Veeva Study Training.\n<\/li>\n<\/p>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>TMF Archive<\/strong> <br \/>\nAccelerate TMF archival with a singleclick archival initiation process. Plus, leverage built-in prerequisites to ensure archival readiness, control access to archived data and documents, and search, filter, and report on archived content.\n<\/li>\n<\/p>\n<\/ul>\n<h3>About Veeva Clinical Operations<\/h3>\n<p>\n<strong style=\"color:orange\">Veeva Clinical Operations<\/strong> empowers clinical teams with a unified platform for efficient trial execution.<br \/>\nStreamlined processes and improved data visibility from startup through closeout accelerates timelines<br \/>\nand enhances collaboration across sponsors, sites, and CROs.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Enabling Greater Trial Collaboration in the Cloud with Veeva eTMF.<\/p>\n","protected":false},"featured_media":11744,"parent":0,"template":"","class_list":["post-7695","resources","type-resources","status-publish","has-post-thumbnail","hentry","resource-social-hide-social-icons","resource-area-20-clinical-operations","resource-product-20-etmf","resource-type-product-briefs"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/7695"}],"collection":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources"}],"about":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/types\/resources"}],"version-history":[{"count":6,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/7695\/revisions"}],"predecessor-version":[{"id":88869,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/7695\/revisions\/88869"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/11744"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=7695"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}