Host: The Japanese Society of Toxicology
Japan Society of Quality Assurance GLP Division has discussed computerized system and quality assurance of electronic data in test facilities for promotion of electronization in non-clinical testing operation. In recent years, it has proposed the optimum methods for management and quality inspection by analyzing the guidance on management of computerized system by OECD, guidance on Data Integrity by MHRA.
Based in these discussions, we will explore the issues and solutions in the view of Data Integrity regarding handling of approvals of electronic records and utilization of external IT resources such as clouds, which seems important in home working, assumed in non-clinical test. Furthermore, we will refer to remote inspection, which is increasing in contract studies.
