Easy DEA Compliance Using Axway's 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, whilst ensuring real-time compliance with American Drug Enforcement Administration (DEA) regulations.

CSOS is compliant with CFR21 Part 11 and meets FIPS140 requirements, enabling organisations to replace the DEA’s costly, paper-based Form 222 by the electronic Form e222. By providing all 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 eliminates billions in costs from the health-care supply chain and drastically reduces delivery times.

CSOS generates complete audit trails that show all archived orders, acknowledgements and shipping documents. What’s more, 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, Health-care Information Systems Implementation

CSOS is easy to implement because it uses pre-configured profiles for existing CSOS customers, including the “Big Three” pharmaceutical distributors, 70% of regional distributors and many of the top pharmaceutical manufacturers and retailers. CSOS also provides a provisioning framework wizard, so that thousands of pharmacies can be easily added 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 checks them using FIPS-validated order verification and Certificate Revocation List (CRL) checking,
• Routes orders to supply chain applications or securely forwards them to distribution centres.