Florence Compliance Guidelines for South Africa

Florence’s Compliance team has reviewed South African Health Products Regulatory Authority (SAHPRA) regulations and confirmed that the use of electronic systems such as Florence is compliant in South Africa.

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

  • South African Good Clinical Practice: Clinical Trial Guidelines
  • Guideline on Oversight and Monitoring in Clinical Trials
  • Regulations Relating to Research with Human Participants

SAHPRA Regulatory Compliance

South African guidelines refer to the US Food and Drug Administration (FDA) 21 CFR Part 11 to ensure adequate electronic signatures. Part 11 is the backbone of Florence’s compliance stance, and Florence meets all technical requirements to be a Part 11 compliant system. Florence has reviewed related FDA guidance documents to understand the FDA’s current thinking around Part 11, and implemented these recommendations into Florence’s Site Enablement Platform.

  • For additional information on how Florence is Part 11 Compliant, we have a frequently asked questions page available here.

  • If you are looking to review your current Part 11 compliance, refer to this checklist for Part 11 Compliance.

  • This article provides insight into how the FDA’s draft guidance on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations addresses the use of technology in clinical trials.

Additional Resources

Florence customers have access to additional resources to support Part 11 compliance efforts, reach out to your Florence contact for additional information!

  • Florence product specific Part 11 checklists

  • User Acceptance Testing Validation Templates
  • Shared Responsibility Model

  • SOP templates

  • Full listing of regulations Florence complies with globally

Privacy

Florence’s Site Enablement Platform can be used in compliance with the Protection of Personal Information Act in South Africa.

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