Shiseido Company, Limited Kakegawa Factory

Adopted MasterControl as a system to support quality assurance activities in both the pharmaceutical and cosmetics divisions

Improving process efficiency through digitalization of QA operation management

Background and challenges

  • Paper-based management of deviations, changes, CAPA, etc. and data entry for annual review and search purposes were inefficient.
  • Paper-based operations required a lot of time and effort to check the progress of matters in circulation, and entailed a risk of loss.
  • Notifications to persons in charge of a gate in each case were emailed with scanned paper documents, which was also cumbersome.


Selection points

  • A system specialized in QA operations management with simple data handling in CSV form and excellent data integration
  • Deployment at relatively low cost with selection of modules to meet the needs
  • Adopted by over 1,000 organizations worldwide and 45 in Japan, including prominent pharmaceutical companies and the FDA.

Project overview and implementation approach

  • Implementation scope: deviation, change, and CAPA management
  • Go-live in a relatively short period of time from the start of the project
  • Successful operation realized through form and workflow settings for each of the pharmaceutical and cosmetics divisions on a single instance
  • Achieved smooth implementation without rework by CRP-based introduction method


Introduction effects (customer feedback)

 〇 Optimization and efficiency of operations

  • Enabled appropriate work allocation by automating and visualizing progress management.
  • Improved efficiency through workflow optimization and automated linkage of each QA work material
  • Sped up processes such as case searches and annual reviews and achieved higher efficiency and better knowledge management
  • Approval from out of the office and working from home enabled with cloud servers

 〇 Enhanced accountability

  • Audit trail and timestamp help prevent backdating and tampering
  • The reliability of business processes improved as well by locking in the necessary steps






Shiseido Company, Limited Kakegawa Factory


Company Name: Shiseido Company, Limited Kakegawa Factory
Address: 1120, Nagaya, Kakegawa-shi, Shizuoka
Business: Manufacture of cosmetics and pharmaceuticals