On 07 August 2020, the OECD made available their long-awaited OECD Draft Advisory Document on GLP Data Integrity for public comment.
The document gives guidance on;
- the responsibilities from data generation to archive
- principles of data integrity
- establishing data criticality and inherent integrity risk
- designing systems and processes to assure data integrity
- definitions of terms and interpretation of requirements
In March 2018 the UK took the lead in data integrity with the publication by the MHRA ‘GXP’ Data Integrity Guidance and Definitions. This new document will enable OECD member states to be aligned with best practices in the industry.