Data integrity is an essential concept for regulated drug manufactures in today's digital age. In recent years, infractions related to data integrity have been noted in several Food and Drug Administration (FDA) warning letters (483's), import alerts, and consent decrees. Since 2017, Data Integrity has been a major audit concern for regulatory agencies in both North America and Europe.

Concerns about data integrity compliance has cause panic among many in the life science industry resulting in an over abundance of caution. Many managers as a result are falling into the trap of over-control, hence the colloquialism, "Death by Compliance." The main symptoms are the implementation of unnecessary controls, which either result in unnecessary costs, and/or an overabundance of procedures that virtually back producers into an audit corner. Worse, this over-control frequently has little to no impact on patient health. This is particularly true as it applies to environmental monitoring equipment.