BruckEdwards Inc. specializes in helping pharmaceutical suppliers and purchasers implement and comply with the Drug Enforcement Administration’s (DEA) Controlled Substance Ordering System (CSOS) by providing strategic consulting, implementation review, as well as purchaser enrollment support and training.
As program director and chief architect of the DEA’s CSOS program during its 6 year development lifecycle, our co-founder, Mr. Steven Bruck brings unequaled understanding of the DEA’s regulations and Public Key Infrastructure (PKI) expertise to our customers’ engagements. Mr. Bruck managed and played an integral part in the development of the following CSOS foundation:

• System Design and Architecture
• Certificate Policy
• X.509 v3 Certificate Profile

BruckEdwards keeps your CSOS deployment on schedule and ensures that it meets DEA’s extensive security regulations through the following service offerings.

Strategic Planning

Implementing CSOS is more than just buying a certified product. Because these products are designed to “snap-in” to a customer’s existing IT environment they leave certain infrastructure and compliance responsibilities to the customer, and these are not covered in the vendor’s audit. Regardless of the ordering model, supplier or purchaser, we help our customers develop end-to-end CSOS business processes and system architecture designed to deliver DEA compliance.

Implementation Support

We offer a complete suite of proprietary CSOS development tools. Our comprehensive Requirements Tracking System enables our customers to quickly visualize how their end-to-end system complies with DEA’s CSOS regulations. This tool enables our customers to document the full scope of affected systems and to identify the validation logic that must be implemented to comply with CSOS. We supplement this with detailed process models and interface specifications to fully specify system design and eliminate guesswork.

Compliance Review

No one understands the DEA’s new regulations better than BruckEdwards. We advised DEA during their development. We translate this direct CSOS subject matter expertise into the most comprehensive set of compliance tests available. Whether implementing an off the shelf product, or developing a customized solution, we work with our customers to ensure end-to-end CSOS compliance across all systems involved with the transaction. By linking our CSOS Test Suite and Requirements Tracking tools, our customers can identify what system services are complaint and focus development resources where they are needed.

Customer Enrollment Support

Deploying CSOS to an entire purchasing department can be challenging at best. For organizations that use Power of Attorney (POA) to manage or centralize controlled substance ordering, enrolling these users must be done quickly, accurately and without complication. Private keys must be stored securely to ensure reliable and long-term access, eliminating costly disruption of ordering processes. BruckEdwards helps supply chain purchasers navigate through the DEA’s CSOS enrollment process. Leveraging our extensive PKI experience, we streamline the digital certificate retrieval process and ensure that private keys are safeguarded according to DEA specifications.

Training

Equally important to a successful CSOS deployment is ensuring that all participants have the necessary understanding of CSOS fundamentals. Our comprehensive CSOS training program addresses all aspects of the DEA’s new rule including key management, digital signature, re-enrollment, and transaction archival. Our material provides your staff (or your customers) with the background and knowledge they need to successfully implement and operate CSOS, giving you the peace of mind that you are operationally compliant, and helping you avoid any missteps.

<Download CSOS Overview>