Electronic Records and Signatures (Part 11)

Chiyoda supports full compliance with Part 11 with an MES package, PAS-X.
PAS-X is an MES package by Werum Software & Systems AG, a German company that has the largest market share in the world (as of 2009).
IT Engineering Ltd., a subsidiary of Chiyoda group, is an exclusive dealer of PAS-X in Japan.
PAS-X fully supports Part 11. Several overseas pharmaceutical manufacturers who already introduced PAS-X into their electronic record and signature operations have passed regulatory body inspections.

Overview of PAS-X

Major PAS-X users