In an effort to crack down on illegal use of controlled substances, the U.S. Drug Enforcement Administration (DEA) maintains strict regulations governing pharmaceutical supply chain transactions for regulated drugs. Each time a pharmacy orders a controlled substance, such as oxycodone, from a distributor, or when a distributor orders oxycodone from the manufacturer, a costly, time-consuming and often paper-based process is triggered.
But, just like we have seen across a variety of other supply chain industry segments, the pharmaceutical industry has streamlined compliance workflows and improved supply chain efficiency by migrating to digital orders — using Controlled Substances Ordering Systems that meet DEA requirements.
Axway is proud to announce that Axway B2Bi Version 2.3 has successfully passed the Audit requirements as established by the U.S. DEA for a Drummond Certified™ Controlled Substances Ordering System (CSOS). With this certification, Axway reinforces its commitment to delivering compliant and interoperable solutions for customers that are easy to implement and integrate. Axway B2Bi for CSOS extends Axway’s leadership in this market, which started with Axway CSOS Interchange.
Axway’s solution provides a more efficient, automated alternative to manual, paper-based workflows required for purchasing and distributing Level I and II controlled substances. In order to achieve certification, CSOS vendors must prove that software offerings enable purchasers and suppliers to interchange electronic order forms in a predictable and secure manner that is compliant with DEA requirements.
Drummond’s rigorous audit process is composed of four key aspects: FIPS Validation Audit, Signing and Validation Testing, Application Feature Testing, Archive of Audit Artifacts. This audit process involves product secure design analysis and secure storage testing in addition to validation of the CSOS Signing and Validation operation use cases.
For healthcare supply chain organizations, using a Drummond Certified CSOS solution provides several key benefits including:
- Reduced implementation costs by using software that has already been tested and validated for interoperability
- Assurance that certified solutions have been tested for compliance to industry & technical standards
- Proven ability to truly interface with the systems of your customers and partners resulting in reduced cost and complexity of compliance for your supply chain
About Axway CSOS
Leading manufacturers, distributors, wholesalers and retailers in the pharmaceutical supply chain have relied on Axway’s best-in-class solution to optimize supply chain processes and improve customer experience. Axway participated in the definition of the electronic regulations for controlled substance ordering and has been a leader in the market, helping organizations move from paper to an electronic system. Axway’s solution allows pharmaceutical supply chain organizations to manage every aspect of their digital B2B relationships — including certificate management, partner on-boarding, encryption and signatures — optimizing inventory management and drastically reducing delivery times.
Axway CSOS also generates complete audit trails showing all archived orders, acknowledgements and shipping documents. Axway CSOS provides real-time visibility and alerting to help you be more responsive to your partners and comply with DEA audit requests quickly and efficiently. Using a modern REST-based API architecture and Single-Sign On, the Axway CSOS Signing & Validation service enables integration to your existing customer portal for a seamless user experience.
About Drummond Group
Drummond Group is a global software test and certification lab that serves a wide range of vertical industries. In healthcare, Drummond Group tests and certifies Controlled Substance Ordering Systems (CSOS), Electronic Prescription of Controlled Substances (EPCS) software and processes, and Electronic Health Records (EHRs) – designating the trusted test lab as the only third-party certifier of all three initiatives designed to move the industry toward a digital future. Founded in 1999, and accredited for the Office of the National Coordinator HIT Certification Program as an Authorized Certification Body (ACB) and an Authorized Test Lab (ATL), Drummond Group continues to build upon its deep experience and expertise necessary to deliver reliable and cost-effective services. For more information, please visit http://www.drummondgroup.com or email DGI@drummondgroup.com.