International Journal on Science and Technology

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Power BI as a Single-Source-of-Truth Platform for FDA-Regulated Environments: Capabilities, Compliance Gaps, and Implementation Guidance

Author(s) Suchitra Venkatesan
Country United States
Abstract Microsoft Power BI has seen broad enterprise adoption as a business intelligence and analytics platform. Organizations operating under U.S. Food and Drug Administration (FDA) jurisdiction increasingly seek to leverage Power BI as a "Single Source of Truth" (SSOT) for operational and quality data. This paper critically evaluates Power BI's architectural capabilities against the regulatory requirements imposed by 21 CFR Part 11 (Electronic Records and Signatures), 21 CFR Parts 211 and 820 (cGMP and QSR), Good Clinical Practice (ICH E6 R3), and FDA data integrity guidance. The analysis identifies functional strengths — including role-based access control, dataset certification, and integration with Microsoft's compliance ecosystem — alongside substantive gaps: the absence of a native audit trail within Power BI datasets, no built-in electronic signature workflow, and a full validation burden placed on the regulated entity. The paper then provides a structured risk register and implementation checklist to guide quality assurance and IT teams in deploying Power BI in a compliant, defensible manner. The conclusion is honest: Power BI can support an SSOT architecture in regulated environments, but only as a visualization and reporting layer over a validated, integrity-controlled data infrastructure. It should not be treated as a standalone regulated system.
Keywords 21 CFR Part 11, Computer System Validation, Data Integrity, FDA Compliance, GAMP 5, Microsoft Power BI, Quality Management Systems, Single Source of Truth.
Field Engineering
Published In Volume 17, Issue 2, April-June 2026
Published On 2026-05-13
DOI https://doi.org/10.71097/IJSAT.v17.i2.11326
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