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White Paper

Data Integrity: What is it and Why is it Important?

Introduction

After two and a half years of releasing a draft version, in December 2018, the U.S. Food and Drug Administration (FDA) published the finalized guidance document entitled “Data Integrity and Compliance with Drug CGMP”. Through the response of the public’s comments, the agency offered more details around their thinking of current best practices for the “design, operation and monitoring of systems to maintain data integrity.1 The aim for this document was to give clarity of data integrity’s role in Current Good Manufacturing Practice (CGMP), as required in 21 CFR parts 210, 211, and 212. The FDA has always maintained the goal of drug manufacturers ensuring data is complete, consistent, and accurate, and therefore trustworthy and reliable. The published guidance is intended to assist manufacturers in addressing prominent identified data integrity gaps. It points towards implementation of best practices, to address issues that can create risks to the reliability and the integrity of data produced.