Laboratories produce vast amounts of data in many types and forms. All this data has the potential to inform and advance the business, or to be analysed further using Artificial Intelligence or Machine Learning to drive deeper insight, but only if it can be put into context and delivered in a useful format to the people who need it to make informed decisions.

Owing to widespread data falsification and poor data management practices, data integrity and compliance with good manufacturing practice (GMP) regulations are currently a major topic in the pharmaceutical industry. To aid our understanding of data integrity concerns, regulatory authorities have issued guidance documents on the topic. This article will give an overview of this guidance and review specific requirements for computerized systems.