Florence’s Compliance Team has reviewed regulations set forth by the Pharmaceuticals and Medical Devices Agency (PMDA) and confirmed that the use of electronic systems such as Florence is compliant with requirements in Japan. 

Florence complies with numerous regulations within Japan, which directly facilitate the use of Florence across various areas, including electronic document management, electronic signatures, remote monitoring, and remote source data verification.

  • Ministerial Ordinance on Standards for the Conduct of Clinical Trials of Pharmaceuticals

  • Japanese Electronic Record Electronic Signature Guideline

  • Procedure for Remote Inspection as a Part of Compliance Inspection on  Drugs and Regenerative Medical Products

  • Privacy Considerations: Florence’s Site Enablement Platform can be used in compliance with the Act on the Protection of Personal Information.

Additional Resources

Florence customers have access to additional resources to support their compliance efforts, reach out to your Florence contact for additional information! 

  • User acceptance testing validation templates

  • Shared responsibility model

  • SOP templates

  • Full listing of regulations Florence complies with globally

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