\nWith 32 manufacturing sites operating across 150 countries, AstraZeneca needed a globally consistent, real-time solution to digital validation.\n<\/p>\n
\nAn over-reliance on paper, combined with distinct, site-specific processes, had increased compliance risks, reduced visibility, and led to duplicative effort over time. \u201cEach site was writing a user requirements specification (URS) for the same qualification activity,\u201d recalls Anup Samantaray, AstraZeneca\u2019s IT quality capability lead for operations IT. \u201cIf the equipment doesn\u2019t change, the requirements shouldn\u2019t change either.\u201d\n<\/p>\n
\nGiven its ambitious goal to launch 23 new medicines by 2030, the global biopharma chose not to delay and selected ³Ô¹Ï±¬ÁÏ Validation Management<\/a>. By unifying digital validation with ³Ô¹Ï±¬ÁÏ QMS<\/a> and ³Ô¹Ï±¬ÁÏ QualityDocs<\/a>, AstraZeneca now benefits from:<\/p>\n \nThe transition to unified digital processes has given AstraZeneca a paperless validation approach that improves compliance. As Samantaray notes, \u201cWe\u2019re not printing paper and creating binders. The data integrity is high, and quality and compliance are increasing across the board.\u201d\n<\/p>\n \nHaving initially assessed the quality technology landscape, Samantaray\u2019s team found an industry fraught with gaps and lacking solutions to track real-time information.\n<\/p>\n \nA long-standing partnership with ³Ô¹Ï±¬ÁÏ offered the chance to address this by integrating business processes across quality and validation. When QMS, QualityDocs, and Validation Management are unified, all validation and quality activities can happen in one place. \u201cA lot of the work in validation stems from an issue or deviation occurring, resulting in a CAPA. With our tightly coupled integration, the system triggers in the same place, providing a seamless way to go from quality management into validation management,\u201d explains Samantaray.\n<\/p>\n \nTeams can now leverage a single source of truth \u2014 all data is centralized while quality events and documents are linked and can be attached to validation activities. This standardized approach ensures data reusability and consistent quality while improving audit readiness.\n<\/p>\n \nAs Validation Management is a natural extension of the Vault Platform, users encounter a familiar interface and no longer have to switch between different systems: \u201cThe look and feel of validation is similar, which is really helpful,\u201d says Samantaray.\n<\/p>\n \nWhile traditional on-premises software quickly becomes stagnant and requires costly \u2018major-version\u2019 upgrades every few years, AstraZeneca now benefits from three annual ³Ô¹Ï±¬ÁÏ releases of updated features and new innovations. \u201cOne of the best features of ³Ô¹Ï±¬ÁÏ Quality Cloud is that you\u2019re truly in continuous improvement mode \u2014 we\u2019re no longer creating big programs to upgrade systems every three or four years,\u201d points out Samantaray. \u201cIt means we can be agile, keep current, and adopt innovations like AI in a fast way.\u201d\n<\/p>\n \nFollowing a 2025 go-live at a greenfield site in China, AstraZeneca\u2019s rest-of-world rollout continues into 2026.\n<\/p>\n \nThe anticipated impact of Validation Management will be clear and measurable. Before the implementation, quality events connected to validation consistently rose every year, from 4000 in 2022 to over 6000 in 2025. With Validation Management, projected event figures for 2026 predict an overall decrease for the first time, driven by more efficient, right-first-time validation processes. Initial data after go-live indicates event cycle times are on track to fall by 20%.\n<\/p>\n \nAs more sites adopt Validation Management, the team will determine program success and site-specific adoption by continuing to monitor:<\/p>\n \nIn the future, Samantaray\u2019s team plans to further optimize digital validation by focusing on:<\/p>\n \nSamantaray adds, \u201cGone are the days of executing a test script with pen on paper. Everything\u2019s electronic and generated in the system. From a manufacturing standpoint, sites will be free to do other things because of the efficiency gains.\u201d\n<\/p>\n\n
Pivot to paper-free validation<\/h2>\n
Faster, right-first-time processes<\/h2>\n
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