The document has been harmonised with existing DI guidelines, e. g. the US FDA, as far as possible. Similar to the FDA, the WHO continues to observe increasing numbers of data integrity violations and took this as an opportunity to develop its own guideline on the topic.
“Possible causes for this may include (i) too much reliance on human practices; (ii) the use of computerized systems that are not appropriately managed and validated; and (iii) failure to adequately review and manage original data and records,”
the guideline says.
The structure of the guideline is clear and straightforward:
In terms of content, the wheel might not be reinvented in this draft, but a clear structure and language speak for the document. The examples of quality risk management and data integrity assessments are well worth mentioning, as well as the ten examples of good documentation practices in data integrity.
The comment period will be open until 15 January 2020. The rest of the timetable foresees processing the feedback by May 2020. However, a final version is not to be expected before the end of next year.