Compliance Frameworks in Pharmaceutical IT: A Comparative Analysis
A detailed comparison of key compliance frameworks in pharmaceutical IT, including FDA 21 CFR Part 11, GDPR, HIPAA, and GxP, with implementation strategies and best practices.
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Articles tagged with “regulatory”
Cloud-Based vs. On-Premise RTSM Solutions: A Comparative Analysis
An in-depth comparison of cloud-based and on-premise Randomization and Trial Supply Management (RTSM) solutions, analyzing security, compliance, cost, and operational considerations for pharmaceutical companies.
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.