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FDA 21 CFR Part-11 Compliance Checklist

An extensive checklist on electronic document management and workflow for clinical trials in order to comply with FDA 21 CFR Part-11.

Review a comprehensive list of FDA 21 CRF Part 11 compliance requirements, examine your current workflows, and 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 21 CFR Part 11 Compliance Checklist will help you check your current operating procedures and systems against FDA 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.

Download 21 CFR Part 11 Compliance Checklist