{"id":75936,"date":"2024-02-21T13:00:20","date_gmt":"2024-02-21T12:00:20","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?post_type=customer-stories&p=75936"},"modified":"2026-01-31T01:06:44","modified_gmt":"2026-01-31T00:06:44","slug":"ucb-streamlines-change-control-and-variation-management","status":"publish","type":"customer-stories","link":"https:\/\/www.veeva.com\/eu\/customer-stories\/ucb-streamlines-change-control-and-variation-management\/","title":{"rendered":"UCB"},"content":{"rendered":"

³Ô¹Ï±¬ÁÏ Quality to RIM Connection will Link Processes<\/h2>\n

\nEvery year, UCB introduces thousands of post-approval changes that impact product registrations. But disconnected quality
\nand regulatory processes make managing variations difficult, time consuming, and
\nprone to delays.\n<\/p>\n

From Manual to Automated Handoffs<\/h2>\n

\nWhile expanding their ³Ô¹Ï±¬ÁÏ footprint to include ³Ô¹Ï±¬ÁÏ QMS<\/a> and ³Ô¹Ï±¬ÁÏ Registrations<\/a>, UCB seized the opportunity to further streamline variation management with the ³Ô¹Ï±¬ÁÏ Quality to RIM Connection. UCB\u2019s goal was to eliminate manual handoffs and improve process visibility with automated two-way data exchange between quality and regulatory systems. Closing information gaps would accelerate regulatory approvals and help the quality team make timely product release decisions. UCB is now working with ³Ô¹Ï±¬ÁÏ to align their RIM and quality data models before implementing the ³Ô¹Ï±¬ÁÏ-delivered integration.\n<\/p>\n

\"\"<\/p>\n

\n“By aligning the RIM and quality data models, we can have change control and regulatory events 100% synchronized, so it should be a massive saving in time and effort.”
\nDarren Nevell, IT Lead, Core Regulatory & QA Apps, UCB<\/span>\n<\/p><\/blockquote>\n

Increased Visibility and Alignment<\/h2>\n

\nWith the ³Ô¹Ï±¬ÁÏ Connection in place, quality and regulatory teams will stay in sync while working efficiently in their own systems. Regulatory will be automatically notified when change controls are requested, approved, closed, or cancelled and the quality organization will have real-time visibility into regulatory impacts and health authority approvals.\n<\/p>\n

\nHarmonizing the variation management process across quality and regulatory departments will enable UCB to shorten cycle times, increase information transparency, minimize regulatory risk, and avoid product distribution delays. Looking ahead, UCB plans to implement the ³Ô¹Ï±¬ÁÏ Clinical Operations to RIM Connection so clinical and regulatory teams can seamlessly share product, study, and site documents.<\/p>\n","protected":false},"excerpt":{"rendered":"

UCB eliminates manual handoffs and improves process visibility with automated two-way data exchange between quality and regulatory systems.<\/p>\n","protected":false},"featured_media":62775,"parent":0,"template":"","product-link-list":[],"class_list":["post-75936","customer-stories","type-customer-stories","status-publish","has-post-thumbnail","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/75936"}],"collection":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories"}],"about":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/types\/customer-stories"}],"version-history":[{"count":0,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/75936\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/62775"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=75936"}],"wp:term":[{"taxonomy":"product-link-list","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/product-link-list?post=75936"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}