H WHO Guidelines H WHO Guidelines
as of 2019 - 03 - 18
H.17 WHO: Guidance on good data and record management practices (Technical Report Series, No. 996 (2016), Annex 5)
Background
1. Introduction
2. Aims and objectives of this guidance
3. Glossary
4. Principles
5. Quality risk management to ensure good datamanagement
6. Management governance and quality audits
7. Contracted organizations, suppliers and service providers
8. Training in good data and record management
9. Good documentation practices
10. Designing and validating systems to assure data quality and reliability
Validation to assure good documentation practices for electronic data
11. Managing data and records throughout the data life cycle
12. Addressing data reliability issues
13. References and further reading
References
Further reading
Appendix 1
Expectations and examples of special risk management considerations for the implementation of ALCOA (-plus) principles in paper-based and electronic systems
Special risk management considerations for controls to ensure that actions and records are attributed to a unique individual
Legible, traceable and permanent
Special risk management considerations for legible, traceable and permanent recording of GXP data
Contemporaneous
Special risk management considerations for contemporaneous recording of GXP data
Original
Special risk management considerations for review of original records
Special risk management considerations for retention of original records and/or true copies
Accurate
Special risk management considerations for assuring accurate GXP records
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