This document is the first release of the EU Data Quality Framework (DQF) for medicines regulation
and defines high-level principles and procedures that apply across EMA’s regulatory mandate. This
framework provides general considerations on data quality that are relevant for regulatory decision
making, definitions for data quality dimensions and sub-dimensions, as well as their characterisation
and related metrics. It provides an analysis of what data quality actions and metrics should be
considered in different use cases and introduces a maturity model to guide the evolution of automation
to support data-driven regulatory decision making.

This document is intended to be a general resource from which more focused recommendations can be
derived for specific regulatory domains with specified metrics and checks. See figure 1 for a
summarised representation of the key points of the DQF.

Please access the Full Document here https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/data-quality-framework-eu-medicines-regulation_en.pdf