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.
Back to Articles
Articles tagged with “validation”
Navigating Regulatory Compliance in RTSM Systems for Clinical Trials
A comprehensive guide to regulatory requirements and best practices for implementing compliant Randomization and Trial Supply Management (RTSM) systems in clinical trials, covering FDA, EMA, and global standards.