IT Systems in Pharmaceutical Operations: Ensuring Data Integrity, Compliance, and Public Safety

Abstract

Pharmaceuticals have witnessed revolutionary information technology deployment evolution from simple administrative systems to complex infrastructures directly impacting public health outcomes and regulatory compliance. This systematic review discusses the various roles played by information technology systems throughout pharmaceutical operations, with a focus on data integrity mechanisms, regulatory compliance frameworks, enterprise architectural patterns, and integration of artificial intelligence for improved quality assurance. Pharmaceutical activities produce large volumes of data over drug lifecycles that cover clinical trials, manufacturing, distribution, and post-market monitoring, necessitating stringent technical controls such as automated timestamping, cryptographic authentication, and end-to-end audit trail functionalities guaranteeing ALCOA+ compliance principles. Global regulatory bodies have developed strict regulations covering electronic record integrity and computerized system validation, with more and more pharmaceutical manufacturers required to implement advanced governance frameworks. Modern challenges involve orchestrating advanced system integrations, providing consistent data quality across diverse platforms, ensuring strong cybersecurity controls, and regulatory compliance in multiple jurisdictions. The integration of sophisticated architectural patterns, such as self-healing integration meshes, data mesh architectural patterns, Zero Trust paradigms, and event-driven systems, solves these complexities along with real-time operational intelligence. Artificial intelligence solutions advance quality assurance in terms of document review automation, anomaly detection, predictive maintenance, and detection of pharmacovigilance signals. Innovative technologies such as blockchain for supply chain integrity, federated learning for collaborative analytics, digital twins for optimization of processes, and quantum computing for molecular simulation are breakthrough opportunities that will revolutionize pharmaceutical operations and enhance therapeutic development at the same time as upholding strict safety standards.