Easy DEA Compliance with Axway Controlled Substance Ordering System (CSOS)

Axway’s Controlled Substance Ordering System (CSOS) makes it easy for buyers and suppliers of regulated pharmaceuticals to reduce operational expenses and increase security while ensuring real-time compliance with U.S. Drug Enforcement Administration (DEA) regulations.

CSOS is compliant with CFR21 Part 11 and meets FIPS140 requirements, enabling organizations to replace the DEA’s costly paper-based Form 222 with the electronic Form e222. By providing all of the functionality you need to manage an electronic B2B relationship — including certificate management, trading partner/community management, secure communications, encryption, digital signatures, alerting, and tracking — CSOS is eliminating billions in costs from the healthcare supply chain and drastically cutting delivery times.

CSOS generates complete audit trails that show all archived orders, acknowledgements, and shipping documents. And real-time visibility and alerting allows you to be more responsive to your partners and helps you comply with DEA audit requests quickly and efficiently.

Hassle-Free Healthcare Information Systems Implementation

CSOS is easy to implement because it leverages pre-configured profiles for existing CSOS customers, including the “Big Three” pharma distributors, 70% of regional distributors, and many of the top pharmaceutical manufacturers and retailers. CSOS also provides a provisioning framework wizard for easily adding thousands of pharmacies to the CSOS trading community.

For buyers such as pharmacies, practitioners, and distributors, regardless of size, CSOS:

• Integrates simply and seamlessly with the procurement system.
• Presents the e222 for signature on screen in human-readable format.
• Securely transmits orders with guaranteed delivery and receipt.
• Fully supports validated digital signatures, document workflow, and archiving.

For suppliers, such as manufacturers and distributors, CSOS:

• Provides validation and fulfillment of e222 orders.
• Easily adds large groups of pharmacies to the trading community via a wizard.
• Accepts encrypted orders and verifies them using FIPS-validated order verification and Certificate Revocation List (CRL) checking.
• Routes orders to supply chain applications or securely forwards them to distribution centers.