Introduction
It is important that there is an understanding of how data integrity is defined when considering establishment of a compliant working environment and process. The FDA defines data integrity as “completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA)” The aim for this document is to give clarity of data integrity’s role in Good Manufacturing Practice (GMP), as required in 21 CFR parts 210, 211, and 212.