The purpose of this document is to describe the requested and designed behavior of the VerdaCore system.
All specifications defined within this document will be tested within the Operational Qualification phase of the VerdaCore system validation process.
VerdaCore is a web-based software as a service application providing centralized randomization and clinical drug supply dispensations to patients. It also functions as a powerful clinical drug supplies management system on its own by input about patient dispensations.
VerdaCore compiles trial configuration, drug supply movements, patient visits, drug dispensations, depot inventory and shipment status data to ensure each site can randomize and treat patients.
VerdaCore collects data keyed in by system administrators, site and drug depot users. Authorized users have 24/7 secure access and can execute functions to update data through a secure web login, compliant with electronic signature.
VerdaCore maintains information about multiple types of data to perform its tasks: Study, sites, pharmacies, depots, destruction facilities, users, patients, kits and more.
Contained within VerdaCore are existing and configurable process flows that define its drug supply management capabilities. Parameters are entered to define the Study’s requirements for VerdaCore to perform drug distribution activities for a trial. Building blocks for supply management start with dose units, which build into drug products, kit types, and shipments. All of these components are customizable and easily tracked in VerdaCore.
Controlled data access allows users to see only the data points they require. Built-in and user-defined queries allow users quick, customized subsets of data relevant to the user’s Role.
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