Data Integrity

Data Integrity in Clinical Research: Audit Trail Review as a Key Tool

Data Integrity in Clinical Research: Audit Trail Review as a Key Tool A recent position paper from the eClinical Forum and the Society for Clinical Data Management highlighted the value of audit...

How Data Integrity Supports a Smooth Transition to Pharma 4.0

The coming pharmaceutical industrial revolution, Pharma 4.0, is an implementation of new systems into the various manufacturing processes leading to an automated production. Introduction of these...

Quality & Compliance

Data Integrity 101: Is your data compliant?

Data integrity has recently been in the agency spotlight. In part because of the draft data integrity guidance issued April 2016, but primarily due to an increased number of inspection findings...