WHO GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT PRACTICES - draft for comment

GOOD MANUFACTURING PRACTICE (cGMP) REGULATORY TRENDS AND QA
1

WHO published working document QAS/15.624 - GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT PRACTICES, a draft document which can be commented until end of November 2015.

This guidance summarize existing principles of good practices for data and records management in GxP regulated areas.
Moreover, provided examples show how these principles may be applied to current technologies and business
models.

Find draft document under link:

http://www.who.int/medicines/areas/quality_safety/quality_assurance/Guidance-on-good-data-management-practices_QAS15-624_16092015.pdf