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.