SmartSignals Supplies Clinical Supply Chain The easiest way to collaborate and control supplies Master inventory logistics Achieve full traceabilityA GxP 21 CFR part 11 compliant history of all inventory transactions is available at the touch of a button. Offer the longest shelf lifeResponsive labeling and packaging means items are prepared after they are ordered, so stock doesn’t sit or expire. Tackle mid-study disruptionsEver-changing clinical trials require an agile supply chain that can handle unpredictable enrollments and amendments. OFTEN COMBINED WITH: Randomization & Trial Supply Management Forecasting & Planning Supply Accountability Why choose SmartSignals? 1 Cloud-Based Solution Only Signant Health offers a cloud-based solution designed specifically for inventory management. SmartSignals empowers organizations of all sizes to effectively plan, monitor, and execute your clinical supply chain. 2 Real-Time Visibility Gain real-time visibility across disparate systems by integrating the SmartSignals Clinical Supply Chain system with CMOs, external inventory systems, and reporting platforms. SmartSignals supports your clinical supply chain by: Controlling all random and sequential codes to maintain study blinding Logging a comprehensive history for all inventory units Preventing unauthorized countries and sites from receiving supplies Providing a full audit trail Generating email notifications Benefits of SmartSignals include: Configuration to tailor usage for site and sponsor needs Lot traceability to quickly replace supplies in the event of a recall Time stamps and e-signatures to provide a full audit trail Electronic Batch Record (EBR) application to achieve fully GxP compliant batch records Warehouse Management System (WMS) handheld application to support warehouse use GS1 barcode standard compatibility to permit standard labeling and electronic data interchange We support your clinical trial labeling needs Creating the various labels required in complex, long-term studies can be tedious but not with Signant Health. From design to routing and approval, our configurable solution positions your compliant text, pictograms, and barcodes on clinical labels. Our secure database maintains a library of phrases and translations to improve your scalability. Frequently Asked Questions How can Signant’s system help my organization be ready for GMP inspection? The SmartSignals Supplies inventory system is GMP compliant at point of purchase. Our team can also assist in authoring the necessary processes and procedures to further guarantee a compliant audit. Is your system compliant with the upcoming DSCSA 2023 requirements? Our highly configurable SaaS solution fully satisfies the FDA requirements for pharmaceutical and biologic organizations under the Drug Supply Chain Security Act (DSCSA) regulations coming into effect by 2023. The DSCSA outlines critical and mandatory steps for pharmaceutical and biologic sponsors and manufacturers to have a fully electronic genealogy system of record for package level tracing. Lot recall and full traceability is available to the end user regardless of supply chain strategy or location. Can the solution manage the clinical supply chain from API to finished goods? Our inventory system not only manages the supply chain from API to finished goods, but it also manages all the components that are inherent in the clinical supply chain. Is your system cloud based? Yes, the entire SmartSignals Supplies solution suite is cloud hosted (AWS). Want to learn more? Add clinical supply chain to control your study supplies – contact our team today. Connect With Us
Achieve full traceabilityA GxP 21 CFR part 11 compliant history of all inventory transactions is available at the touch of a button. Offer the longest shelf lifeResponsive labeling and packaging means items are prepared after they are ordered, so stock doesn’t sit or expire. Tackle mid-study disruptionsEver-changing clinical trials require an agile supply chain that can handle unpredictable enrollments and amendments.
Only Signant Health offers a cloud-based solution designed specifically for inventory management. SmartSignals empowers organizations of all sizes to effectively plan, monitor, and execute your clinical supply chain.
Gain real-time visibility across disparate systems by integrating the SmartSignals Clinical Supply Chain system with CMOs, external inventory systems, and reporting platforms.
Controlling all random and sequential codes to maintain study blinding Logging a comprehensive history for all inventory units Preventing unauthorized countries and sites from receiving supplies Providing a full audit trail Generating email notifications
Configuration to tailor usage for site and sponsor needs Lot traceability to quickly replace supplies in the event of a recall Time stamps and e-signatures to provide a full audit trail Electronic Batch Record (EBR) application to achieve fully GxP compliant batch records Warehouse Management System (WMS) handheld application to support warehouse use GS1 barcode standard compatibility to permit standard labeling and electronic data interchange