Chapter 11: Safety Databases and Technology in Pharmacovigilance
Synopsis
Author
Miss Veera Naga Lalitha Nakkina,
PharmD Scholar, Department of Pharmacy Practice, Koringa College of Pharmacy, Korangi, Kakinada, Andhra Pradesh, India
Abstract
The complexity of modern pharmacovigilance relies entirely on a robust technological infrastructure capable of managing millions of adverse event records while maintaining strict regulatory compliance. The specialized software ecosystem is dominated by safety databases such as Oracle Argus and ArisGlobal LifeSphere, which serve as the central repositories for global safety data. These systems differ fundamentally from clinical databases by focusing on event-centric workflows rather than visit-centric data points. A critical component of this technology is the E2B standard, an international XML schema that governs the electronic transmission of Individual Case Safety Reports (ICSRs) between pharmaceutical companies and regulatory authorities, ensuring that data is interoperable across borders. Beyond standard adverse events, the safety database must also handle specialized scenarios such as Medication Errors, which reflect preventable process failures, and Product Quality Complaints, which link manufacturing defects to patient safety. Integrating these diverse data streams into a single, validated system ensures that the sponsor maintains a complete and compliant view of the product's safety profile, enabling rapid reporting and accurate signal detection while meeting the stringent validation requirements of GAMP 5.
Keywords: Safety Databases (Argus/ArisG), E2B Transmission, Medication Errors, Product Quality Complaints (PQC), System Validation
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