Data Integrity in the Age of Metadata and Big Data

To adapt to the present reality concerning data management, MHRA published GXP Data Integrity Guidance and Definitions, aligned with texts issued by PIC/S, WHO and EMA (1–4). Released in March 2018, the guidance seeks to achieve a reliable relationship between generation of raw information and related decision-making that occurs during drug manufacturing. Metadata will play a key role in achieving this relationship and it takes a prominent place in the guidance.