Practice for CSV of Cloud-Based GxP Business Systems:

Abstract

  It could be worthwhile to make proposals related to practical methods for CSV of cloud-based GxP business systems, given that any guidelines for CSV of those systems have not yet been issued by the Ministry of Health, Labor and Welfare. In this study, we will show development activities, verification activities and a supplier audit, all of which our group experienced, for a SaaS-type electric document management system for GxP businesses, leading to an attempt to share the best practices in CSV of cloud-based GxP business systems. The feasibility of our proposal related to the CSV life-cycle management of cloud-based GxP business systems at the previous PDA Japan Annual meeting will also be discussed in this study.