Systematic Managerial Analysis of Digital Data Management Adoption in a Regulated Research Facility

Abstract

This Special Problem examined the adoption of a digital data management approach in a GLP-compliant research facility undergoing organizational transition. The work addressed a recurring performance gap between the intended benefits of electronic workflows—timely review, approval, traceable record control, and reduced reliance on paper—and the observed instability of a previously implemented global Document Management System (DMS) workflow. To guide a defensible managerial response within a regulated environment, Systematic Managerial Analysis (SMA) was applied as the primary framework, integrating situation analysis, problem identification and specification, problem analysis, decision analysis, and potential problem analysis. Evidence was drawn from a review of relevant policies and SOPs, stakeholder discussions with Quality Assurance, IT support, and laboratory users, and analysis of organizational artifacts, including internal communications, IT service records, and a representative case illustrating workflow failure behavior. Thematic analysis of DMS- related tickets and supporting documentation indicated persistent issues affecting accessibility, scheduler stability, data capture/transfer, and workflow routing— conditions that contributed to operational delays and reduced user confidence in the electronic process. A structured decision evaluation compared feasible record-approval alternatives under compliance and resource constraints. The analysis supported a locally governed solution: validation and implementation of the chromatography data system’s built-in electronic signature capability through a controlled change process. While validation demonstrated technical suitability for identity, integrity, and traceability expectations, findings emphasized that sustainable adoption depends on organizational readiness, stakeholder alignment, and trust in system reliability. The study concludes that effective digital transformation in regulated laboratories requires not only compliant technology, but also robust governance and deliberate change management to ensure long-term integration.