If vendors don’t offer compliant features like audit trails, don’t help you create SOPs, or don’t assist with system validation, they could compromise the integrity of your clinical studies.
It is crucial your eRegulatory vendor can prove they are fully compliant with all FDA Part 11 regulations, requirements, and recommendations. They should also prove their compliance with international regulatory and privacy standards.
Florence has been independently validated against all regulations set by the FDA, industry sponsors, IRBs, and research sites. We have compliantly served clinical trial sites across 45 countries and 6 continents.*
The information presented here is for informational purposes only and is not for implementation in operations. Please consult official clinical trial guidance documents for operational use.
*Data as of 24Mar22
Here are a few compliance resources to review when examining an eRegulatory solution for clinical trial document management.