Bracket’s SmartSupplies PMD solution provides a protocol driven framework coupled with bidirectional integration to manufacturing systems (ERP), IVR services and B2B partners. With SmartSupplies PMD, Clinical protocol requirements are translated into accurately packaged and distributed investigational drug products. SmartSupplies PMD is designed to dramatically increase the efficiency, accuracy and compliance of the clinical supply process with immediate benefits including:
Bracket’s SmartSupplies RAR solution was designed by clinical teams. SmartSupplies RAR identifies the materials that need to be reconciled and provides both Online and Remote data entry modes. Reconciliations performed using the remote mode, can easily be imported back into the SmartSupplies RAR application to synchronize the data.
Based on the principles of a Clinical Trial, SmartSupplies Forecasting enables forecasters to model study protocols, enrollment and material requirements to produce time-phased demand schedules that are easily modified and shared between departments. Forecasting the demand is only half the equation. SmartSupplies Forecasting is also designed to enable the Clinical Manufacturing team to develop manufacturing scenarios for meeting the forecasted demand. These lot-based scenarios factor in yields, lot expiry dates, reserves and more.
Bracket’s SmartSupplies Forecasting solution provides a protocol driven framework coupled with optional integration to ERP/MRP systems, IVRS systems and CTMS systems. With SmartSupplies Forecasting, Clinical Forecasters and the Clinical Manufacturing team share mutual benefits that include:
Import and approve translations and attach translation certificates directly within the phrase and translation library. Each phrase can then be approved for a particular country or countries, ensuring regulatory compliance throughout your labeling process.
The SmartSupplies LRA solution increases staff efficiency by allowing you to build re-usable templates – automatically associating the country-specific phrases with each new template, and allowing the user to customize the phrases to be included or excluded from a particular type of label.
Approved label designs can then be utilized in the web-based print request and completion application for the printing of production labels.
The LDP web-based printing application enables users to enter desired values for the variable data and import randomization files for a list of unique ID’s to be inserted into defined placeholders. The system’s powerful electronic routing and approval process verifies that the printed labels meet both study and packaging run requirements prior to printing.
All label designs (artwork) and printed labels are stored within the system’s secure database framework for improved reliability, scalability and universal access over the network.
SmartSupplies LDP can be purchased as a stand-alone product or as a fully integrated SmartSupplies product. When combined, the SmartSupplies LRA phrases and translations library and robust routing and approval engine provides unmatched capability for quickly producing labels that are compliant with industry and regional regulations.
SmartSupplies EBR provides an activity and process step library to accurately record the activities within each required process step for batch record fulfillment. A library of activities and process steps help streamline the batch record process by providing re-usability of these activities across multiple type of manufacturing/packaging jobs.
The SmartSupplies EBR solution increases staff efficiency by allowing users to build re-usable master batch records based on material types prior to execution of the manufacturing/packaging jobs.