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Florence Healthcare
Unleashing the next era of clinical trials intelligence. Florence powers shared workflows and AI-augmented automation across sites and sponsors.
stacklist.com/florence-healthcare-demo
Unleashing the next era of clinical trials intelligence. Florence powers shared workflows and AI-augmented automation across sites and sponsors.
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21 CFR Part 11 - FDA Requirements for Electronic Records
Title 21 CFR Part 11 establishes FDA regulations on electronic records and signatures, requiring clinical trial organizations to implement controls including audits, system validations, and audit trails. Florence provides a fully compliant eRegulatory platform with features like custom roles, document audit trails, and verified eSignatures to help research sites, sponsors, and CROs meet these complex regulatory requirements.
Built for AI agentsACO · 1033 tokens
Summary
Title 21 CFR Part 11 establishes FDA regulations on electronic records and signatures, requiring clinical trial organizations to implement controls including audits, system validations, and audit trails. Florence provides a fully compliant eRegulatory platform with features like custom roles, document audit trails, and verified eSignatures to help research sites, sponsors, and CROs meet these complex regulatory requirements.
Tags
fda-compliance · 21-cfr-part-11 · eregulatory · clinical-trials · electronic-signatures · audit-trails · data-integrity
Key entities
Title 21 CFR Part 11 (concept, 0.99) · FDA (organization, 0.99) · Florence (organization, 0.98) · electronic records and electronic signatures (concept, 0.97) · eRegulatory (concept, 0.96) · system validation (concept, 0.95) · audit trails (concept, 0.95) · United States (location, 0.9)
Classification
reference · language en · status final
Provenance
claude-haiku-4-5 via @stacklist/be@0.1.0, confidence 0.85, 2 Jul 2026