Industry-specific definitions of data integrity
Data integrity in pharma & life sciences:
US FDA definition (21 CFR Part 11, Electronic Records): "Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be assignable, legible, original or copy recorded simultaneously, and accurate."
The FDA (Food and Drug Administration) uses the ALCOA principle to define a standard for data integrity. ALCOA Plus (ALCOA+) extends these conditions to include Complete, Consistent, Enduring, and Available.
As regulators become more stringent in their inspections, it is critical to be able to demonstrate compliance. The parameters of the ALCOA principle create a benchmark for holistic documentation here, which other industries also follow.