Host: The Japanese Society of Toxicology
Based on "Draft Advisory Document on GLP Data Integrity" (OECD GLP Working Group) and "Items to be implemented by the sponsor with respect to external contracts archiving facility" (PMDA, 25th GLP training workshop. 2013), we investigated that how the sponsor should assure the quality of the electronic data using the Cloud to comply with GLP requirements in Japan. In this report, referring to the operation of overseas data centers using SaaS systems, we will explain the points that sponsors should check regarding the electronic data management in the Cloud to ensure the reliability of GLPs.
