Florence’s Compliance Team has reviewed regulations set forth by the European Medicines Agency (EMA) and European Commission (EC) and confirmed that the use of electronic systems such as Florence is compliant with general EMA/EC requirements. 

Florence complies with numerous regulations within the European Union (EU) and the European Economic Area (EEA), which directly facilitate the use of Florence across various areas, including electronic document management, electronic signatures, remote monitoring, and remote source data verification.

  • EudraLex Volume 4, Annex 11

  • Guideline on computerized systems and electronic data in clinical trials 

  • EMA on the content, management and archiving of the TMF (paper and/or electronic)

  • EMA Reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) for management, audit and inspection of clinical trials

  • EMA implementation of ICH E6(R2) Guideline for GCP

  • Recommendation paper on decentralized elements in clinical trials

Image of globe with security checkpoint to symbolise Annex 11

EU Annex 11: How to Stay Compliant

For additional information on how to stay compliant with the requirements of Annex 11.

eBook: 21 CFR Part 11 vs. EudraLex Annex 11

Refer to this eBook for a comparison between US FDA 21 CFR Part 11 and EudraLex Annex 11.

Guide to the EMA’s Guidelines

An overview of the EMA’s Guidelines on Computerized Systems and Electronic Data Management in Clinical Trials.

GDPR Compliance

Florence is compliant with the General Data Protection Regulation (GDPR) as the foundational basis for global privacy. If you are looking to understand how GDPR affects your clinical trial operations, refer to this guide. 

Florence is active under the EU-U.S. Data Privacy Framework (DPF), the UK Extension to the EU-U.S. DPF and the Swiss-U.S. DPF to provide adequate data protection.  

Refer to our privacy policy for additional information. 

National Considerations

When conducting research within the EU/EEA,  it is important to consider national provisions applicable in each Member State, which may be more stringent than those of the region as a whole. The Florence Compliance Team has looked into regulations in key member states to ensure that Florence can meet local regulatory and privacy requirements in addition to those of the EU/EEA as a whole.

Additional Resources

Florence customers have access to additional resources to support their 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 European regulations, refer to this article.