Articles tagged with “alcoa”

Structured Product Labeling (SPL): A Guide to Data Integrity

Learn why Structured Product Labeling (SPL) is replacing PDF for pharma labeling. This guide explains the FDA mandate, XML standards, and how SPL ensures data i

30 min read

11/23/2025

structured product labeling spl data integrity pharmaceutical labeling regulatory affairs fda regulations hl7 alcoa+

AI in Good Documentation Practice (GDocP): ALCOA+ & Compliance

Explore how AI impacts Good Documentation Practice (GDocP) and ALCOA+ principles in life sciences. Learn about efficiency gains, data integrity risks, and new r

40 min read

11/14/2025

good documentation practice gdocp ai in pharma data integrity alcoa+gxp compliance 21 cfr part 11 regulatory compliance

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

Validating Generative AI in GxP: A 21 CFR Part 11 Framework

Explore a risk-based framework for validating generative AI in GxP systems. Learn how to meet 21 CFR Part 11 rules, ensure data integrity, and apply CSA princip

40 min read

10/28/2025

generative ai 21 cfr part 11 gxp computer software assurance data integrity pharmaceutical validation alcoa+life sciences fda compliance eu annex 11