Articles tagged with “system-validation”

Learn 21 CFR Part 11 requirements for electronic records. This guide analyzes cost-effective FDA compliance strategies for small biotechnology startups.

Choosing a GxP ELN? Compare Benchling, IDBS, and LabArchives on features for 21 CFR Part 11 compliance, system validation, and ALCOA data integrity principles.

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

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.

An explanation of regulatory requirements for audit trails under 21 CFR Part 11 and EU Annex 11, covering automation strategies, data integrity measures, and the latest 2025-2026 regulatory developments including the Annex 11 draft revision and FDA CSA guidance.

Explore 21 CFR Part 11 compliance for electronic records, signatures, and AI in GxP. Covers key elements, FDA guidance (including finalized CSA and AI credibility framework), and controls for data integrity and audit-ready systems. Updated February 2026.

Explore US pharmaceutical automation compliance, covering FDA regulations like cGMP & 21 CFR Part 11, Pharma 4.0 trends, challenges, and best practices.

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.