PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Review
Consideration in Vital Importance of Electronic Data Utilization in the Digitized Big Data Era
Daikichiro Murakami
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JOURNAL FREE ACCESS

2018 Volume 20 Issue 1 Pages 11-17

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Abstract
 Although there are laws to enable the transition to the electronic original of the record document on paper in Japan, safekeeping stands still on the paper originals in large quantities, and the reality in its transitional progress to computerization in Japan is so slow as compared with the situation in the Western countries.
This subject has been discussed in the ES (e-signature) group of the Japan PDA ERES committee more than one year and the main issue was “need of the computerization” and “a risk when domestic electronic extension was late”.
Also, we have examined pros and cons focused on some methods of concrete computerization, that we paid attention to electronization from paper-oriented system.
The committee delivered the presentation that featured the subject of “the computerization of the paper original” in the committee session in Japan PDA Annual meeting held in Kobe-city in the end of November, 2017, so some essential points are hereunder described for future subjects.
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© 2018 Parenteral Drug Association Japan Chapter
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