WHO Annex 5 Guidance on Good Data and Record Management Practices, 2016
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In 2016, the World Health Organization (WHO) published Annex 5 Guidance on Good Data and Record Management Practices.
This guidance contains definitions of the following terms:
- ALCOA (attributable, legible, contemporaneous, original and accurate)
- Data Integrity
- Metadata
- Audit Trail
- Static and dynamic record formats
- Backup and Archival
- Computerized system
The guidance also provides recommendations regarding:
- Design and validation for data integrity
- System access restrictions
- Unique user logins
- Audit trail reviews
- Original records and true copies
- Lab system and data controls
- Electronic signatures
- Audits and controls for IT suppliers and service providers (e.g., cloud)
- Periodic GDP training for employees and IT service providers
