An explanation of regulatory requirements for audit trails under 21 CFR Part 11 and EU Annex 11, covering automation strategies and data integrity measures.

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.

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

This article details AI's role in biotech sample management, covering traditional workflows, challenges, AI innovations, regulatory issues, and future outlook.

Learn about the 2025 job market for Computer System Validation (CSV) professionals. Understand CSV's critical role in regulated industries for data integrity and patient safety.

Learn about regulatory compliance software in pharmaceuticals, covering GMP, GLP, GCP, FDA 21 CFR Part 11, and EU Annex 11 standards for data integrity.

Compare GAMP 4 and GAMP 5. Learn key differences in their approaches to system validation, risk management, system classification, and integration of modern technologies.

This guide explains GAMP 5, its principles, and lifecycle for computerized system validation in pharma, covering regulatory compliance and real-world applications.

Learn what Computer System Validation (CSV) is, its crucial role in pharmaceutical and biotech compliance, ensuring data integrity and regulatory adherence for patient safety.

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.