From Capital Investment to Operational Excellence: Navigating the Interdependent Software Lifecycle in GxP-Regulated Pharmaceutical Environments
Year: 2026
Type: article
Abstract: The pharmaceutical industry is currently navigating a paradigm shift driven by "Pharma 4.0," where the digital transformation of laboratory and production processes is no longer optional. This paper examines the increasing complexity and interdependence of core software systems-specifically ERP (S/4HANA), LIMS, and LES.As software lifecycles shorten, traditional Capital Expenditure (CAPEX) models and rigid Waterfall project management frameworks create significant friction. The paper also explores the financial shift from a Capital Expenditure (CAPEX) to an Operating Expenditure (OPEX) model. This change is presented as a critical factor for maintaining agility, ensuring continuous GxP validation, and effectively avoiding the "Sunk Cost" trap often associated with large-scale digital implementations.
Author: Zubler, Yves
Language: English
Subfield: Management Information Systems
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W7140142853
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