Automating Audit Trail Compliance for 21 CFR Part 11 & Annex 11
An explanation of regulatory requirements for audit trails under 21 CFR Part 11 and EU Annex 11, covering automation strategies and data integrity measures.
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Articles tagged with “system-validation”
21 CFR Part 11: Electronic Records, Signatures, AI, GxP Compliance
Explore 21 CFR Part 11 compliance for electronic records, signatures, and AI in GxP. Covers key elements, FDA guidance, and controls for data integrity and audit-ready systems.
Pharmaceutical Automation Compliance: US Regulatory Frameworks
Explore US pharmaceutical automation compliance, covering FDA regulations like cGMP & 21 CFR Part 11, Pharma 4.0 trends, challenges, and best practices.
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.