CSOS—Controlled Substance Ordering System

Optimizing Controlled Substance Supply Chain Ordering through CSOS strategy, architecture and training

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 foundational elements:

• CSOS System Architecture and Design
• CSOS System Engineering and Integration
  • CSOS PKI Certificate Policy
  • CSOS X.509 v3 Certificate Profile
• CSOS Implementation

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

• Training—If you’re working to understand the details of the DEA CSOS regulations, how these will impact your CSOS implementation, or need more people to get up to speed with the CSOS requirements quickly, then our in-depth training is the answer. BruckEdwards’ unique qualifications from our team’s direct program and technical leadership of the CSOS program provide our clients with the understanding necessary to successfully implement a CSOS solution quickly. Our subject matter experts (SMEs) conduct a two-day on-site meeting with your CSOS implementation team to cover the CSOS regulations, and to summarize the specific provisions of the regulations that are relevant to your buy-side and sell-side implementations.
• Strategic Planning and Architecture— 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.