Florence Compliance Guidelines for Brazil

Florence’s Compliance Team has reviewed regulations set forth by the Brazilian Health Regulatory Agency (Anvisa) and confirmed that the use of electronic systems such as Florence is compliant with requirements in Brazil.

Florence complies with numerous regulations within Brazil, such as the following which directly support the use of Florence ranging from topics of electronic document management, electronic signatures and remote monitoring.

  • GCP of the Americas
  • RDC No. 506 to provide for the rules for carrying out clinical trials with investigational advanced therapy products in Brazil
  • RDC No. 548 to provide for the conduct of clinical trials with medical devices in Brazil

Privacy Considerations

Florence’s Site Enablement Platform can be used in compliance with the Brazilian General Data Protection Law (LGPD).

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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