Data Integrity

Features

Data Integrity in the Trenches: A Look into Quality Control Lab

11 January 2019

Pharmaceutical Engineering magazine’s March–April 2016 Special Report 1 highlighted the increasing...

1International Society for Pharmaceutical Engineering. “Special Report: Data Integrity.” Pharmaceutical Engineering 36, no. 2 (March–April 2016): 39–67.

Press Releases

ISPE GAMP RDI Guide: Data Integrity – Key Concepts Released

25 October 2018

ISPE announced the release of their latest Guide, ISPE GAMP ® RDI Good Practice Guide: Data Integrity – Key Concepts . This publication provides detailed practical guidance to support data integrity within a regulated organization. "In recent years...

Technical

Getting Ready for Pharma 4.0™

1 September 2018

The amount of data collected in a typical pharmaceutical manufacturing operation is staggering, yet research shows that much of this information is rarely used for anything more than compliance. New technologies such as big data, artificial intelligence, machine learning, and deep learning permit unprecedented analysis of realtime data and can even predict trends in processes and operations....