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

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.