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Clinical Trial Electronic Document Management and Workflow FDA 21 CFR Part-11 Checklist

Extensive document and workflow checklist on everything you need to consider regarding FDA 21 CFR Part-11

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What you will learn:

  • Review comprehensive list of FDA 21 CRF Part 11 requirements
  • Examine your current workflows
  • Explore compliant solutions
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The essential requirements checklist of operating electronic document storage and management in clinical trials.

As it is our mission at Florence to simplify clinical trial document and project management, we also aim to provide sites and sponsors with a more natural way to access, understand, and apply the FDA’s guidance on eSource and eRegulatory.

This comprehensive checklist will help you check your current operating procedures and systems against FDA Part-11 requirements, as well as give you an overview of how Florence complies with Part-11 requirements.

Ensure compliance is a top priority at your research site.

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