30 August - 2 September 2022
In recent years, the topic of data integrity has led to increased activity among international authorities, resulting in numerous guidelines issued by these institutions. Among others, the WHO (World Health Organization) published in the Technical Report Series, No. 996, 2016, as Annex 5 a "Guidance on good data and record management practices".
In 2021, the WHO replaced this guidance in the Technical Report Series, No. 1033, 2021, with the "Guideline on data integrity" with the following structure:
With this new version of the guideline, the WHO is attempting to harmonise the document with other international guidelines on data integrity, including the "MHRA GxP data integrity guidance and definitions, revision 1", the "FDA guidance for industry Data integrity and compliance with CGMP - questions and answers" and the "PIC/S Good practices for data management and integrity in GMP/GDP environments".
Data governance is dealt with very extensively. In particular the responsibility of senior management for the implementation of the system and the regulations is emphasised. The contents of such a data governance programme are described in detail:
Ultimately, the document is another guideline that joins the various previous guidelines on data integrity.
Source: WHO Guideline on data integrity; WHO TRS 1033, 2021 starting on page 135