Data Integrity In The Life Sciences

This eBook is a collection of articles from the Data Integrity In The Life Sciences series, the purpose of which is to highlight contemporary insights and relationships to key quality systems in order to elevate the most important topics and advance improvements in the collective quality culture. The series started with the publication of “When And How To Implement Data Integrity Practices In The Product Development Lifecycle,” which presented that “data integrity is established (well or poorly) with the earliest capture of development data that will later inform clinical research. It then extends to chemistry, manufacturing, and controls (CMC); regulatory review and approval; and, ultimately, commercial production.” Other articles in the series discuss specific data integrity improvement opportunities within individual quality systems with specific operational examples.

These articles represent current thinking across life sciences industry segments, from human cell and gene therapy to animal health, from vaccines and biologics to medtech and companion diagnostics. These articles also consider many transformative technologies in life sciences such as artificial/ augmented intelligence (AI), the Internet of Things (IoT), and data-driven personal medicine. The combination of concise explanations of complex topics with real-world examples make the articles easy to understand and the recommendations relatable to the reader.