As the pandemic rages on and challenges like and disruptions continue, digital intelligence is the one thing that industry leaders can count on for competitive advantage. predicted that by 2023, 75% of life sciences manufacturers will invest in intelligent supply chain solutions to enable resilience and prevent future disruptions during health emergencies such as COVID-19.
Increasing regulations are also sparking digital innovation across life sciences. For example, organizations are required to share updated supply chain data with trusted partners for compliance with the final phased-in regulations of the . Initially passed in 2013, the latest batch of requirements from this act will require pharmacies, wholesalers, and manufacturers to track and report drug shipments for legitimacy between authorized trading partners. That鈥檚 where Spherity Credentialing Service CARO comes in, an app that provides updated information proving a dispenser鈥檚 trading partner status.
鈥淲hen a pharmacist in a tiny dispensary in North Dakota has suspicions about a received drug shipment, they send a verification request to a global pharmaceutical manufacturer that has numerous wholesalers in between them and the pharmacy,鈥� said Dr. Oliver Nuernberg, chief product owner of Life Sciences at SAP. 鈥淎utomating the credentialing process builds transparency and trust between indirect partners, immediately surfacing the pharmacy鈥檚 credentials as an authorized trading partner. This saves time and costs with greater information accuracy and fewer delays, strengthening an organization鈥檚 ability to meet DSCSA regulations.鈥�
Available on , Spherity Credentialing Service CARO is integrated with聽, a cloud-based network solution that helps organizations comply with other provisions of the U.S.聽DSCSA. For example, drug traceability is another U.S. DSCSA mandate. Pharmaceutical manufacturers can also use the information hub to help law enforcement trace drug shipments by serial numbers, supporting audits that help keep counterfeit medications out of the supply chain.
Intelligent Automation Strengthens Health of Drug Supply Chain
Spherity functions as a digitally encrypted wallet that captures and stores a dispenser鈥檚, or any other trading partner鈥檚, verified identity data, including address, notarized documents such as articles of incorporation, as well as updated U.S. state and DEA license information. By digitizing previously manual data collection and distribution tasks between systems, the app eliminates historical time lags that often resulted in outdated information.
鈥淚n the past, information about trading partner status was manually imported on a monthly basis from spreadsheets provided by third parties. An order might come from a wholesaler or dispenser whose license expired or was revoked weeks or even months ago,鈥� said Nuernberg. 鈥淓lectronic credentialing surfaces accurate information much faster, helping organizations automatically prove compliance with regulations, including license type as required to dispense various drugs.鈥�
Once a pharmacy鈥檚 identity is verified in their digital wallet, pharmaceutical companies would also be informed on an ongoing basis if the state or federal agency didn鈥檛 renew that license or revoked it for any reason.
Verified Partner Identity for Supply Chain Safety
Verifying a dispenser鈥檚 identity isn鈥檛 as easy as it sounds. Drug supply chains are complex, involving manufacturers, wholesale distributors, re-packagers, and logistics companies long before the goods reach pharmacies for dispensing. Having an app that automatically verifies a dispenser鈥檚 identity in real or near real time is designed to support regulatory compliance and help make drug supply chains more secure. Anticipating the 2023 regulations, some global pharmaceutical manufacturers and wholesalers have been testing the app with measurable results.
鈥淯sing the app, organizations have told us that they can securely and more easily verify trading partners and generate audit-ready records,鈥� said Georg J眉rgens, manager of Industry Solutions at Spherity. 鈥淲ith electronic interactions, they can trust that a trading partner is legitimate because due diligence has been conducted that proves identity. The app is easy to get up and running and has already increased efficiencies.鈥�
J眉rgens added that the app鈥檚 interoperability with different systems is designed to help meet regulatory mandates around electronic data sharing, easing collaboration between trusted partners along the clinical supply chain.
Digitalized Business Innovation
Eliminating counterfeit drugs in the legitimate supply chain is just the beginning of what鈥檚 possible in a fully digitalized life sciences supply chain. Pharmaceutical companies will be able to bring in and ramp up new, trusted suppliers faster. Intelligence will only grow with greater automation for business and patient value.
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