La OECD ha publicado el 22 de abril de 2016, una nueva guía Nº 17 sobre sistemas informáticos.
OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING Number 17 Advisory Document of the Working Group on Good Laboratory Practice Application of GLP Principles to Computerised Systems
This document introduces a life cycle approach to the validation and operation of computerised systems. It emphasises risk assessment as the central element of a scalable, economic and effective validation process with a focus on data integrity. The intention of this document is to provide guidance that will allow test facilities to develop an adequate strategy for the validation and operation of any type of computerised system, regardless of its complexity, in a GLP environment.
Consulta la guía en el siguiente enlace, http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2016)13&doclanguage=en