Florence’s Compliance team has reviewed US Food and Drug Administration (FDA) regulations and confirmed that the use of electronic systems such as Florence is compliant with FDA requirements.

FAQs: About Part 11

For additional information on how Florence is Part 11 Compliant, refer to our frequently asked questions page.

Checklist: Part 11

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

FDA’s Draft Guidance

Explore how FDA’s draft guidance addresses the use of technology in clinical trials.

FDA Regulatory Compliance

21 CFR Part 11 is the backbone of Florence’s compliance stance, and Florence meets all technical requirements to be a Part 11 compliant system. Additionally, Florence has reviewed related FDA guidance documents to understand the FDA’s current thinking around Part 11 and other key regulations, and implemented these recommendations into Florence’s Site Enablement Platform.

In conformance with these best practices, Florence can be used for:

  • Electronic document management

  • Electronic signatures

  • Remote monitoring

  • Remote source data verification

Beyond Part 11

Our review of regulations in the US goes beyond Part 11 compliance. Florence can be used in compliance with key predicate rules, such as:

  • 21 CFR 50 Protection of Human Subjects

  • 21 CFR 56 Institutional Review Boards

  • 21 CFR 812 Investigational Device Exemption

  • 21 CFR 312 Investigational New Drug Applications

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

Florence eConsent

For additional information on how Florence’s eConsent system can be used in compliance with FDA regulations, refer to this article.

Privacy and Security

Florence systems are compliant with the Health Insurance Portability and Accountability Act (HIPAA). For additional HIPAA Guidance on Technology and Clinical Research, reference this article.

For California residents, Florence is compliant with the California Privacy Rights Act (CCPA) and honors consumer requests as outlined in the CCPA. Refer to our privacy policy for additional information.