WHO Draft Data Integrity Guidance

The World Health Organization (WHO) has released for comment a draft guideline, Guideline on Data Integrity, with information, guidance, and recommendations to facilitate compliance with data integrity and good practices in documentation and record-keeping requirements. The document does not cover medical devices. The WHO says that where possible, the guidelines has been harmonized with other published documents and should be read with other WHO good practices guidelines and publications.

In line with the current approach to good manufacturing practices, WHO says, the guideline recommends a risk-based approach over the life cycle of data. It says that data integrity risk assessment should be carried out to identify and assess areas of risk.

“Efficient risk-based controls and review of data and documents should be identified and implemented,” the guideline says. “The effectiveness of the controls should be verified.”