{"id":81985,"date":"2025-02-04T22:35:00","date_gmt":"2025-02-04T21:35:00","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?post_type=customer-stories&p=81985"},"modified":"2026-01-31T00:56:40","modified_gmt":"2026-01-30T23:56:40","slug":"empowering-quality-teams-with-unifed-qms-and-data","status":"publish","type":"customer-stories","link":"https:\/\/www.veeva.com\/eu\/customer-stories\/empowering-quality-teams-with-unifed-qms-and-data\/","title":{"rendered":"Customer Story"},"content":{"rendered":"

\n\u201cWe’re now really starting to add value to the business. Not only can we see how to become more compliant and inspection-ready, but we can more readily identify problem areas that the business needs to focus on in order to improve.\u201d
\n– Associate Director of Tech Ops and Quality<\/span>\n<\/p><\/blockquote>\n

\nLike many companies, one biopharma has sped growth and diversified its pipeline through strategic acquisitions and integrations.\n<\/p>\n

\nBy scrutinizing the fit between quality processes and procedures after an integration, business leaders melded best practices within a framework of globalization, harmonization, and simplification. As a result, flexible, out-of-the-box solutions, were added to the company\u2019s own agile practices.\n<\/p>\n

\nThe company also implemented ³Ô¹Ï±¬ÁÏ QualityDocs and ³Ô¹Ï±¬ÁÏ QMS, which had rolled out shortly before an acquisition, to further standardize and harmonize quality data and documentation and reduce manual processes. Up until that point, the company had used a legacy system for both document and quality management. Opting for an agile approach, the company formed a cross-functional implementation team with representatives from IT, compliance, tech ops, quality, and business management.\n<\/p>\n

Agility for data migration success<\/h2>\n

\nThe team\u2019s first challenge was unifying data and documentation within a new ³Ô¹Ï±¬ÁÏ Quality platform, drawing from an old legacy system and the acquired company\u2019s initial ³Ô¹Ï±¬ÁÏ Quality installation.\n<\/p>\n

\nThe company divided implementation into two phases, starting with ³Ô¹Ï±¬ÁÏ QualityDocs and then moving on to ³Ô¹Ï±¬ÁÏ QMS.\n<\/p>\n

\nWhen deciding which QMS features to include, the team took an agile \u201cminimum viable product\u201d approach that allowed everyone to define and agree on the minimum must-haves while allowing for future inclusion of additional value-add features. Leaders also scheduled demos at the end of each sprint to show the team’s achievements before formal testing. These demos allowed the team to \u201cfail fast\u201d and speed design based on quick feedback from business leaders.\n<\/p>\n

Striving for data-driven quality management<\/h2>\n

\nSo far, the new ³Ô¹Ï±¬ÁÏ Quality solution has helped the company harmonize processes for key quality operations including deviations, CAPA, laboratory investigations, audits, customer audits, and complaints. It has also streamlined procedures, pruning more than 60 SOPs and allowing another 125 to be set aside for retirement or updating.\n<\/p>\n

\nThe new QMS has enabled better quality oversight and reporting by establishing consistency and one source of truth for all quality metrics, processes, and workflows. This data-driven foundation will enable the team to create new KPIs in crucial patient-focused areas such as complaints management and add value to the business by improving efficiency.\n<\/p>\n

\nIn addition, establishing a unified quality foundation should make it easier to update governance models.\n<\/p>\n

\nData-driven insights will also help the company\u2019s quality team add business value and contribute to overall operational excellence.\n<\/p>\n

Quality management simplified<\/h2>\n

\nThe new QMS will help improve output from data analytics and master data management, enabling proactive quality and better cross-functional decisions. In the long term, the company expects master data management to become a major focus because it allows closer connections between quality data and data from other departments, such as regulatory and safety.\n<\/p>\n

\nSuch connections will be vitally important when dealing with issues such as changes to IDMP (Identification of Medicinal ³Ô¹Ï±¬ÁÏ) regulations, \u201cQuality departments work with multiple databases and systems but don\u2019t always own the master data. To enable reporting across systems, we need to understand who owns them and how we can best align with them.\u201d\n<\/p>\n

\nThe company appreciates the possibility of aligning QMS and product hierarchy while also connecting ³Ô¹Ï±¬ÁÏ Quality with other Vaults. Such connections improve efficiency by reducing manual processes across functions in areas such as manufacturing change control.\n<\/p>\n

\nFor more insights into ³Ô¹Ï±¬ÁÏ QMS, please watch this demo<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

A biopharma harmonized key quality operations by unifying data and documents in a single platform.<\/p>\n","protected":false},"featured_media":81986,"parent":0,"template":"","product-link-list":[1393,1395,1442],"class_list":["post-81985","customer-stories","type-customer-stories","status-publish","has-post-thumbnail","hentry","product-link-list-veeva-clinical-operations","product-link-list-veeva-commercial-cloud","product-link-list-veeva-rim"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/81985"}],"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":1,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/81985\/revisions"}],"predecessor-version":[{"id":82008,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/81985\/revisions\/82008"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/81986"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=81985"}],"wp:term":[{"taxonomy":"product-link-list","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/product-link-list?post=81985"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}