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GxP Inventory

Centralize visibility and control of clinical IP. 

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Master inventory logistics

Manufacturing and managing supplies is one of the most challenging aspects of a clinical trial. Ensuring the right quantity of clinical trial supplies are available for study participants requires careful management of each step of the supply chain process, from raw material to manufacturing to packaging and labeling finished kits to global distribution.

GxP Inventory enables complete management of the end-to-end supply chain, providing full visibility of all inventory levels, including genealogy and quality release, within a single, cloud-based system.

Why choose Signant SmartSignals GxP Inventory? 

Single Solution Oversight

GxP Inventory provides complete visibility within a single system, eliminating time-consuming and error-prone processes associated with disparate data sources.

Transparent Compliance 

Fully documented QA/QP release processes, and fully 21 CFR part 11 compliant history of all inventory transactions available in real-time.

Power of Integration

GxP Inventory integrates with RTSMs/IRTs, CMO external inventory systems for outsourced supplies, and reporting systems for reliable processes and up-to-date data.

Cloud-Based Solution

Only Signant Health offers a cloud-based solution designed specifically for clinical development inventory management. Our solution suite empowers organizations of all sizes to effectively plan, monitor, and execute your clinical supply chain.

Flexible implementation models to meet all sponsor requirements

Choose from our out-of-the-box Essential implementation, or our fully-configurable Enterprise offering. 


GxP INVENTORY:
ESSENTIAL

Get started right away with a pre-configured version containing the most frequently used elements for inventory production, management, and QA/QP release.​

Suitable for use on a single trial, a single program, or more.


GxP INVENTORY: ESSENTIAL+

​A pre-configured and integrated Inventory management solution that acts as a single system of record for fragmented manufacturing and distribution.

Suitable for use on multiple programs/trials.


GxP INVENTORY: ENTERPRISE

​​Meet more individualized requirements such as sponsor-specific terminology/labels and additional workflow or process options with this robust, custom-configured version.​​

​Suitable for use on single and multiple programs.

Top reasons to select GxP Inventory

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  • Implement this cloud-based, SaaS solution cost-effectively without infrastructure investment.

  • Eliminate time-consuming, manual processes and fragmented data sources by using a single solution.

  • Easily manage rapid and accurate lot recall as needed, saving time and ensuring patient safety and regulatory compliance.

  • Conduct QA/QP release processes simply and electronically at each inventory level, providing full traceability.

  • Leverage industry-leading labeling software, fully interoperable with GxP Inventory.

  • Meet the needs of any budget, protocol, or program with Essential or Enterprise version options

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.  

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Enable sophisticated temperature monitoring within mixed shipments
Seamlessly integrate temperature monitors into pick-and-pack workflows
Ensure the timely release of investigational products to reduce waste, as well as accurate expiry of quarantined medications
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.

FAQs

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. 

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