Volume-1 ,Issue-2, September-2025

Cheminformatics platforms, laboratory information management systems (LIMS), electronic laboratory notebooks (ELNs), clinical data management and electronic data capture (EDC) systems, pharmacovigilance tools, regulatory submission software, manufacturing execution systems (MES), and enterprise resource planning (ERP) are just a few examples of the extremely complex and vital software systems that pharmaceutical companies depend on. All phases of the drug lifecycle, including manufacturing, post-market surveillance, regulatory approval, and discovery and development, are supported by these systems. The majority of pharmaceutical software systems are still closed-source, proprietary, and essentially unsearchable by other parties, despite their scientific significance and technological competence. This review looks at the organizational, legal, regulatory, technical, and economic aspects of this opacity and assesses how it affects cybersecurity, innovation, repeatability, and patient safety. Through a standardization-driven, modular strategy that incorporates verified core systems, interoperable standards, metadata frameworks, privacy-preserving data sharing, third-party audits, and regulatory sandboxes, the study suggests a practical route toward safer transparency.

Keyword: Pharmaceutical software; Proprietary systems; Data integrity; Regulatory compliance; Interoperability; Digital transformation