Data Governance: The Foundation of AI in Pharma
Artificial Intelligence and data-driven decision-making are no longer future concepts—they’re already reshaping how the pharmaceutical industry operates. Smarter tools and faster insights promise real benefits, but their success depends on one critical factor: the quality of the data behind them.
From ensuring traceability and balance in datasets to putting in place secure, well-structured governance frameworks, the way data is managed determines whether AI can truly deliver value. Without robust controls, even the most advanced algorithms fall short.
This video explores the principles of effective data management and governance in GxP and medical device contexts—highlighting why integrity, security, and lifecycle oversight must be priorities for any organisation embracing AI.
Discover how strong data foundations enable innovation with confidence.
Sandra Lacruz
CSV Consulting Line Director
About the Author:
Sandra Lacruz is the CSV Consulting Line Director at Rephine, where she leads global projects focused on Computer System Validation (CSV) and IT Quality Assurance in regulated environments.
Sandra has extensive experience supporting pharmaceutical, biotech, and medical device companies in meeting GxP, FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 requirements. Her expertise spans system validation, digital compliance, and data integrity, helping clients strengthen their IT governance and inspection readiness.
At Rephine, Sandra works closely with clients to ensure that digitalisation and automation are fully aligned with regulatory expectations, driving both compliance and operational excellence.
