Florence eBinders
Florence eBinders is a 21 CFR Part 11 compliant electronic regulatory system that allows users to maintain regulatory documents in a safe electronic, cloud-based environment. An eRegulatory system such as this enables real-time regulatory compliance and risk-reduction in study startup, maintenance, monitoring, audit, inspections, and closeout.
Documents and electronic logs (such as the DOA log) can be uploaded or created and signed electronically with the use of a signing pin/password. Florence has extensive privacy and security controls in place for document protection, including those with PHI.
User access is requested by the consortia through the DMCC Regulatory Support. Roles and permissions are standardized and assigned based on the work an individual is expected to perform in the system.
More information on Florence eBinders can be found on their website. Florence provides an abundance of help articles for registered users.
Because of the potentially sensitive nature of the documents within Florence eBinders, RDCRN users are required to use Duo Two-Factor Authentication for RDCRN before being granted access to the system.
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