{"id":12146,"date":"2016-03-25T18:06:12","date_gmt":"2016-03-25T17:06:12","guid":{"rendered":"http:\/\/www.veeva.com\/eu\/?post_type=resources&#038;p=12146"},"modified":"2025-12-17T11:34:10","modified_gmt":"2025-12-17T10:34:10","slug":"veeva-submissionsarchive-product-brief","status":"publish","type":"resources","link":"https:\/\/www.veeva.com\/eu\/resources\/veeva-submissionsarchive-product-brief\/","title":{"rendered":"³Ô¹Ï±¬ÁÏ Submissions Archive Features Brief"},"content":{"rendered":"<style>\n.veeva-2024 .fa-ul li p {\nmargin-top:5px;\n}\n.veeva-2024 .content-block .fa-check-circle {\ncolor: #f7981d;\nfont-weight: 400;\nfont-size:20px;\n}\n@media (min-width:768px) {\n.veeva-2024 .hero-centered {\npadding: 100px 0;\n}\n}\n@media (min-width:992px) {\n.veeva-2024 .content-block {\nmargin-top: 6rem;\n}\n}\n.veeva-2024 .content-block__sidebar {\ndisplay:none;\n}<\/p>\n<p>.veeva-2024 .content-block__content .stat-box {\nbackground: #eef1f5;\ndisplay: inline-block;\npadding: 10px 30px;\nborder-radius: 16px;\nfont-size: 18px;\nmargin: 5px 5px 20px 5px;\nfont-weight: 500;\n}\n.veeva-2024 .content-block__content .stat-box span {\ncolor:#f5670e;\nfont-weight:600;\n}\n\/* to remove the mobile dropdown *\/\n.veeva-2024 .form-dropdown {\ndisplay: 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-submissions-archive-features-brief-figure-one.png\"><\/p>\n<h2>Complete history of regulatory submissions<\/h2>\n<p><img decoding=\"async\" class=\"img-right d-block d-lg-none\" alt=\"\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2025\/10\/veeva-submissions-archive-features-brief-figure-one.png\"><\/p>\n<p>Regulatory teams often use a patchwork of systems to track historical submissions, creating confusion and slowing responses to health authorities. ³Ô¹Ï±¬ÁÏ Submissions Archive makes it easy to find the right information in a validated cloud environment.<\/p>\n<p>Regulatory teams can store eCTD and non-eCTD electronic submissions (NeeS) and link health authority correspondence to related submissions for a complete view of regulatory communications. Affiliates can download submissions or submission components for reuse in local markets and upload submissions already sent to various health authorities.<\/p>\n<p>³Ô¹Ï±¬ÁÏ Submissions Archive enables companies to import submissions directly from file shares while preserving the eCTD XML backbone, folder structure, and interdocument hyperlinks. Users can navigate documents exactly as they were submitted to regulatory agencies and directly from the repository without needing to download files. An integrated eCTD viewer provides current, sequential, cumulative, and regulatory action views so users can quickly see a submission\u2019s full lifecycle.<\/p>\n<h2>Business Benefits<\/h2>\n<ul class=\"fa-ul\">\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Increased visibility.<\/strong><\/p>\n<p>Comprehensive view reduces time and effort to find and access submission information.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Faster decision-making.<\/strong><\/p>\n<p>Advanced search capabilities help users easily locate information, accelerating timelines.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Improved access.<\/strong><\/p>\n<p>Spend less time maintaining compliance and reallocate time to more strategic tasks.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Unified RIM.<\/strong><\/p>\n<p>Connect end-to-end regulatory processes and improve efficiency as part of the ³Ô¹Ï±¬ÁÏ RIM Platform.<\/p>\n<\/li>\n<\/ul>\n<h2>Features<\/h2>\n<ul class=\"fa-ul\">\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>eCTD and Non-eCTD Import <\/strong><\/p>\n<p>Import final submission packages for your records and future reference. Timely updates ensure regulatory compliance in alignment with regional requirements.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Integrated Viewer <\/strong><\/p>\n<p>Leverage an integrated, cloud-based viewer for eCTD, NeeS, and legacy submission formats, which reduces the number of tools on the regulatory desktop. For eCTD submissions, view and filter XML values to focus on dossier reviews.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>PDF Link Navigation<\/strong><\/p>\n<p>Navigate PDF hyperlinks across documents within a submission, across submissions, and even across applications. There\u2019s no need for separate tools, file shares, or downloading files.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Full Lifecycle Viewing<\/strong><\/p>\n<p>View the complete dossier lifecycle with current, sequential, and regulatory action views. See cumulative changes for each document.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Health Authority Interactions<\/strong><\/p>\n<p>Retain and classify all correspondence with health authorities. View correspondence documents in the context of the application and associated submission.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Dynamic Access Control<\/strong><\/p>\n<p>Use rule-based access control to dynamically calculate permissions that ensure people can see only what they need and nothing else.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>De-duplicate Documents<\/strong><\/p>\n<p>Store documents used in multiple submissions once and only once with the correct leaf details and metadata for each submission.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Smarter Navigation Display<\/strong><\/p>\n<p>Access a document\u2019s complete history of lifecycle operations. See where a document is used, including direct links to each submission.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Bulk Submission Export<\/strong><\/p>\n<p>Quickly export multiple submissions to support product divestitures, collaboration, and outsourced publishing.<\/p>\n<\/li>\n<\/ul>\n<h2>³Ô¹Ï±¬ÁÏ RIM<\/h2>\n<p>³Ô¹Ï±¬ÁÏ Submissions Archive is part of ³Ô¹Ï±¬ÁÏ RIM, which streamlines global regulatory processes on a single, cloud-based platform. This enables life sciences companies to:<\/p>\n<ul>\n<li>Ensure teams are developing reliable regulatory content with high data integrity<\/li>\n<li>Coordinate regulatory efforts across headquarters, affiliates, and partners<\/li>\n<li>Respond faster to changing regulations<\/li>\n<li>Increase end-to-end process efficiency from submission planning to publishing<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Adopt a single global destination for archived submissions and health authority correspondence.<\/p>\n","protected":false},"featured_media":12148,"parent":0,"template":"","class_list":["post-12146","resources","type-resources","status-publish","has-post-thumbnail","hentry","resource-social-hide-social-icons","resource-area-20-regulatory","resource-product-20-submissions-archive","resource-type-product-briefs"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/12146"}],"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":3,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/12146\/revisions"}],"predecessor-version":[{"id":28178,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/12146\/revisions\/28178"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/12148"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=12146"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}