Signant SmartSignals Supplies Clinical Supply Chain The easiest way to collaborate and control supplies Master inventory logistics Achieve full traceability A GxP 21 CFR part 11 compliant history of all inventory transactions is available at the touch of a button. Offer the longest shelf life Responsive labeling and packaging means items are prepared after they are ordered, so stock doesn’t sit or expire. Tackle mid-study disruptions Ever-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 > Download Brochure Why choose Signant 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. Signant 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 Signant 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 Label generation print requests for packaging jobs through Loftware integration Temperature Excursion Management Leverage Signant’s end-to-end Temperature Excursion Management (TEM) solution to efficiently cumulate temperature excursion data across the full supply chain and ensure your patients are only exposed to clinical medications within known stability conditions. Our solution solves the current challenges of fragmented excursion data tracking by providing a longitudinal, comprehensive record of excursions while investigational products are at site or in transit. Download our brochure to learn how our TEM solution is designed to: Download TEM Brochure 1 Enable sophisticated temperature monitoring within mixed shipments 2 Seamlessly integrate temperature monitors into pick-and-pack workflows 3 Ensure the timely release of investigational products to reduce waste, as well as accurate expiry of quarantined medications 4 Support USB and Bluetooth-based temperature monitors to provide earlier access to data We support your clinical trial labeling needs It can be complex to create the medication labels required in global clinical trials. Signant Health has simplified this process through the integration of Signant SmartSignals Supplies with Loftware to provide customers with a seamless label design, approval, and printing process for Investigational Products. This enables customers to rigorously apply regulatory rules, implement industry standard GS1b barcodes, direct booklet/single panel label design and printing, and leverage in-line camera verification of labels. Loftware’s industry-leading labeling capabilities are integrated with user workflows in Signant SmartSignals Supplies, enabling customers to easily manage labeling processes that satisfy regulatory requirements. 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 traceability A GxP 21 CFR part 11 compliant history of all inventory transactions is available at the touch of a button. Offer the longest shelf life Responsive labeling and packaging means items are prepared after they are ordered, so stock doesn’t sit or expire. Tackle mid-study disruptions Ever-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 Label generation print requests for packaging jobs through Loftware integration
Leverage Signant’s end-to-end Temperature Excursion Management (TEM) solution to efficiently cumulate temperature excursion data across the full supply chain and ensure your patients are only exposed to clinical medications within known stability conditions. Our solution solves the current challenges of fragmented excursion data tracking by providing a longitudinal, comprehensive record of excursions while investigational products are at site or in transit. Download our brochure to learn how our TEM solution is designed to: