AI Regulatory & Legal Frameworks for Biopharma in 2025
Examines the 2025 AI regulatory frameworks for biopharma in the U.S., EU, U.K., and Canada. Details compliance obligations for GenAI, GxP, and SaMD.
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Articles tagged with “risk-management”
IEC 62304: Medical Device Software Life Cycle Processes
An overview of the IEC 62304 standard for medical device software. This guide explains its purpose, scope, and required life cycle processes for safety.
Pharmaceutical Industry KPIs for Quality & Compliance
An overview of pharmaceutical KPIs for quality, compliance, and operational excellence. Explores metrics for R&D, manufacturing, and regulatory standards.
GAMP 4 vs. GAMP 5: Key Differences in System Validation
Compare GAMP 4 and GAMP 5. Learn key differences in their approaches to system validation, risk management, system classification, and integration of modern technologies.
Best Practices for Randomization and Trial Supply Management (RTSM) in Phase 3 Clinical Trials
Comprehensive guide on RTSM best practices for Phase 3 trials, covering randomization strategies, global supply chain management, regulatory considerations (FDA), system integration, risk mitigation, and future trends.