Articles tagged with “fda-guidance”

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

AI Medical Devices: 2025 Status, Regulation & Challenges

Analysis of AI medical devices in 2025. Learn about market growth, 950+ FDA-cleared devices, new regulations like the EU AI Act, and key clinical challenges.

50 min read

10/30/2025

ai medical devices medical device regulation software as a medical device fda guidance eu ai act ai in healthcare algorithmic bias

Clinical Trial Phases 1–3: A Comprehensive Guide for Pharmaceutical IT Professionals

A practical guide to clinical trial phases 1–3 for pharma IT: objectives, compliance, costs, and IT infrastructure for modern drug development.

20 min read

5/14/2025

clinical trial phases pharma IT regulatory compliance EDC CTMS FDA guidance GCP CDISC drug development