In September 2015, the World Health Organization (WHO) published a draft guidance document focused solely on data integrity. This is due to recent increases in the number of inspection observations related to data management practices. These WHO recommendations are intended to ensure the integrity of both paper and electronic data and records. Share this with your team, so you can incorporate these practices into your procedures.
What’s new in this WHO Guidance document:
Definitions of Terms:
This draft guidance contains definitions of the following terms:
- Data Integrity
- Metadata
- Audit Trail
- Static and dynamic record formats
- Backup
- Computerized system
WHO Recommendations
The draft guidance also provides recommendations regarding system:
- Design and validation for data integrity
- Access restrictions
- Unique user logins
- Audit trail reviews
- Original records and true copies
- Lab system and data controls
- Electronic signatures
- Controls for IT suppliers and service providers (e.g., cloud)
- Periodic GDP training for employees and IT service providers
This document is open for comments through November 30, 2015. Contact information is in the document for where to direct your feedback.
Obtain a copy of the WHO Draft Guidance here: Guidance on Good Data and Record Management Practices
Do you need more help implementing these recommendations at your organization? Talk to our CSV experts about how you might be affected.