Master Data Governance for Global Drug Launch Readiness in Healthcare Enterprises: A Systematic Framework for Compliance and Operational Excellence

Abstract

Master Data Governance has emerged as a mandatory construct to pharmaceutical business venturing in the intricacies of drug commercialization in the world today, amidst the more complex regulatory demands and shorter market penetration cycles. The pharmaceutical sector has complicated issues which include compliance with regulations in different jurisdictions, implementation of serialization regulations, country-specific labeling necessity, and traceability demands of the supply chain which push complex master data administration talents. The operational necessity extends to competitive advantage: improved launch preparedness, regulatory compliance guarantee, and supply chain resilience, which is the business case of strong Master Data Governance. The incremental value approach of Phased implementation methodologies enables pharmaceutical organizations to build the Master Data Governance maturity incrementally as they address the immediate business requirements and prove the incremental value over the deployment lifecycle. Hierarchical master data architecture assists in global product templates with market extensions that are market-specific and enable the effective management of labeling requirements in multiple regulatory jurisdictions, and maintain consistency in core product information. Serialization and master data systems enable pharmaceutical manufacturers to address the global track-and-trace requirements, as well as obtain strategic gains that can encompass counterfeit prevention, enhancement of visibility across the supply chain, and the possession of speedy recall functionalities. Blockchain-based distributed ledgers, analytics-driven artificial intelligence, and workflow coordination technologies are all available on the technology platforms and have the potential to transform Master Data Governance into a strategic facilitator of operational effectiveness and competitive advantage in global pharmaceutical markets.