Florence Compliance Guidelines for India

Florence’s Compliance Team has reviewed regulations set forth by the Central Drugs Standard Control Organisation (CDSCO) and confirmed that the use of electronic systems such as Florence is compliant with requirements in India.

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

  • Good Clinical Practices For Clinical Research In India
  • New Drugs and Clinical Trial Rules
  • The Medical Devices Rules

Privacy Considerations

Florence’s Site Enablement Platform can be used in compliance with the Digital Personal Data Protection Act in India.

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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