Articles tagged with “ema”

ALCOA+ Principles: A Guide to GxP Data Integrity

Learn the 9 ALCOA+ principles for GxP data integrity. This complete guide explains each attribute, FDA & EMA regulations, and compliance for pharma and life sci

50 min read

10/31/2025

alcoa+data integrity gxp fda guidance ema good manufacturing practice 21 cfr part 11 regulatory compliance

Navigating Regulatory Compliance in RTSM Systems for Clinical Trials

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.

55 min read

4/20/2025

clinical-trials rtsm irt regulatory-compliance fda ema gcp data-integrity validation audit-trails part-11 annex-11