Florence’s Compliance Team has reviewed regulations set forth by the National Administration of Drugs, Food and Medical Devices (ANMAT) and confirmed that the use of electronic systems such as Florence is compliant with requirements in Argentina.

Florence complies with numerous regulations within Argentina, such as the following which directly support the use of Florence for electronic document management and remote monitoring.

  • Regulatory Guideline for GCP

  • Guide for using Decentralized Elements in Pharmacology Studies

  • Guide for Research with Human Beings

Privacy Considerations

Florence’s Site Enablement Platform can be used in compliance with the Personal Data Protection Act and Decree No. 1558/2001, as amended by Decree No. 1160/2010 in Argentina.

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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