PDA Letter Article

Data Integrity in the Age of Metadata and Big Data

by Toni Manzano, bigfinite

Feat 2

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.