PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Volume 18 , Issue 2
Showing 1-4 articles out of 4 articles from the selected issue
Regular Article
  • Cloud CSV Group, ERES (Electronic Records Electronic Signatures) Commi ...
    2016 Volume 18 Issue 2 Pages 25-122
    Published: 2016
    Released: December 20, 2016
    JOURNALS FREE ACCESS
      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.
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