Articles tagged with “audit-trails”

Configure CAPA management in Veeva Vault QMS with this technical guide. Covers data models, 21 CFR Part 820 compliance, and workflow implementation steps.

Explore FDA 21 CFR Part 11 compliance for electronic records and signatures. Learn about validation, audit trails, and data integrity enforcement trends.

Explore GxP audit trail requirements for AI systems. Review 21 CFR Part 11, Annex 11, and ALCOA+ rules for logging training data, prompts, and model outputs.

Explore FDA 21 CFR Part 11 compliance for AI systems. This guide covers validation, audit trails, and data integrity for machine learning in GxP environments.

Updated 2026 guide for IT on 21 CFR Part 11. Covers FDA CSA guidance, AI compliance, electronic records & signatures, system validation, audit trails & data integrity

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.

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

Evaluate LMS platforms for life sciences. Understand key compliance requirements: FDA 21 CFR Part 11, GxP, electronic records, and audit trails for validated training.

Compares NetSuite and SAP ERP systems' technical capabilities and regulatory compliance features for pharmaceutical and life sciences companies.

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.