WHO Draft Guidance on Good Data and Record Management Practices, 9/15

WHO Draft Guidance on Good Data and Record Management Practices, 9/15

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This draft WHO guidance outlines expectations for achieving data and record integrity, reliability, accessability and protection

Description

WHO Draft Guidance on Good Data and Record Management Practices, 9/15

In September, 2015, the World Health Organization (WHO) published Draft Guidance on Good Data and Record Management Practices.

This draft guidance contains definitions of the following terms:

  • Data Integrity
  • Metadata
  • Audit Trail
  • Static and dynamic record formats
  • Backup
  • Computerized system

The draft guidance also provides recommendations regarding: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
  • Controls for IT suppliers and service providers (e.g., cloud)
  • Periodic GDP training for employees and IT service providers

Per WHO committee, the draft should not be displayed on non-WHO websites, so please access via this link:  http://www.who.int/medicines/areas/quality_safety/quality_assurance/Guidance-on-good-data-management-practices_QAS15-624_16092015.pdf

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