News about GMP/cGMP

04.07.2016

WHO: Final Version of Good Data and Record Management Practices

Almost one year after publishing the draft, the WHO has now issued the final version of the Guideline to “Good Data and Record Management Practices”. The document is part of the Technical Report Series No. 996, 2016 and is therein listed as Annex 5.

 

Compared to the draft guideline (we reported) the final document has grown from 40 to 46 pages. A new Appendix 1 has been added. It contains expectations and examples of special risk management considerations for the implementation of ALCOA (-plus) principles in paper-based and electronic systems. These principles require that documentation should have the characteristics of being attributable, legible, contemporaneously recorded, original and accurate (ALCOA). To aid understanding the concepts rather than setting new normative requirements, illustrative examples are provided. The intention is to give explanations as to what these high-level requirements mean in practice and what should be demonstrably implemented to achieve compliance in data management procedures.

With this important guidance WHO bridges the gaps in current guidance when it comes to data management.


Source:

WHO: Good data and record management practices

 



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