Introduction

In today’s highly regulated pharmaceutical and life sciences industries, data is not merely a tool for insight—it is a regulated asset that must be carefully managed, processed, and visualized in a manner compliant with Good Automated Manufacturing Practices (GAMP), 21 CFR Part 11, EU Annex 11, and ALCOA+ principles. Itanta Analytics emerges as a sophisticated, modern analytics platform purpose-built to handle complex industrial and operational datasets while meeting GxP expectations.

This whitepaper explores how the Itanta Analytics Platform can be effectively leveraged within regulated GxP environments. It outlines the platform’s general functionality, describes the data lifecycle journey, evaluates the GxP applicability, and details a case study along with audit considerations. It concludes with a detailed tabular breakdown of GxP audit questions and compliance approaches across the data lifecycle.