Data Integrity: Understanding and Becoming Compliant with GMP and FDA Requirements

Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which ensures the product's quality and public safety.

In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept.

The importance of record-keeping in drug manufacturing can be seen as far back as 1938, when the Federal Food, Drug and Cosmetic (FDC) Act required the safety of new drugs be documented before being sold to the public, with similar regulations instigated in Europe and Japan throughout the 20th century.