Are the UK light years ahead on data integrity?

On 9^th March 2018, the MHRA published their document, ‘GXP Data Integrity Guidance and Definitions’ with the intent of providing ‘confidence in the quality and the integrity of the data generated and be able to reconstruct activities’. The document was followed by the development of the advisory document from the OECD, and three years later, on 20^th September 2021, OECD published its advisory document no. 22 on ‘GLP Data Integrity’.

In the MHRA blog published on 27^th September 2021, the inspectorate confirmed the OECD Advisory Document takes precedence over their document due to the UK membership of the OECD Mutual Acceptance of Data (MAD). It further states that their document was always meant to sit alongside additional regulatory guidance and that there are no plans to revise the MHRA document at this time.

This article hopes to bring some clarity on the impact the duplication of requirements might have on existing processes and to discuss the UK’s exploration of data integrity practices.

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