GxP ELN Software: Benchling vs IDBS vs LabArchives Compared
Choosing a GxP ELN? Compare Benchling, IDBS, and LabArchives on features for 21 CFR Part 11 compliance, system validation, and ALCOA data integrity principles.
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Articles tagged with “system-validation”
21 CFR Part 11 for AI Systems: An FDA Compliance Guide
Navigate FDA 21 CFR Part 11 for AI systems. This article details compliance strategies for validation, audit trails, and data integrity in regulated GxP setting
DocuSign in Pharma: A Guide to 21 CFR Part 11 Compliance
An analysis of how DocuSign is used for electronic signatures in pharma and life sciences. Learn how it can meet FDA 21 CFR Part 11 compliance with its modules.
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.
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. Updated with 2025 FDA CSA guidance and ISPE GAMP AI Guide.