Quality & Compliance
How Mature Is Your Data Integrity? New FDA and EU Regulatory Focus Areas
Data integrity has been in regulators' spotlight for decades, and the expectations for ensuring data integrity are evolving and increasing. This is partly because of the various 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...
Quality & Compliance
CSV Considerations Around Data Integrity
Data integrity is a current hot topic, but not a new one, within the life sciences industries and associated product supply chains. This article will not delve into why there have been so many recent...