Your role and responsibilities
Identify the team responsible for the workflow, the organization’s role, and the requirements your responsible reviewers have established using current FDA information.
DSCSA implementation support
Make drug-tracing workflows easier to operate.
Specialized implementation support for pharmaceutical supply-chain systems, trading-partner data exchange, and operational documentation. We define the work around your organization’s responsibilities and existing systems.
Support for the work behind the requirements.
01
Understand your current process
Review the systems, data exchanges, and operational handoffs involved in your drug-tracing workflows.
02
Connect trading-partner information
Define and implement the agreed data connections, validation steps, and exception handling for your partners and platforms.
03
Test the operational workflow
Work through representative records and review the process for missing information, failed exchanges, and investigation handoffs.
04
Prepare your team to operate it
Provide documentation and a handoff covering the agreed system configuration, responsibilities, and routine checks.
A practical approach
Define the scope before implementation.
The right starting point depends on your people, information, and business goals. We agree the scope together.
- Identify your organization’s role and applicable requirements
- Agree which systems and trading partners are included
- Define access, validation, and human review responsibilities
- Test the agreed implementation before launch
- Use current FDA information when reviewing regulatory requirements
An operational starting point
Follow one exchange from receipt to resolution.
A connection is useful when your team can tell whether the information arrived, whether it matches the expected records, and who owns the next action. A pilot can focus on one partner, exchange type, or exception queue.
- 01
Receive and identify
Record the partner, source, exchange reference, and the point in the operational process. Confirm the agreed destination and data ownership.
- 02
Validate the agreed information
Check the required structure and references against representative records. Keep the original exchange available to the people responsible for review.
- 03
Route an exception
Assign incomplete or inconsistent records to an owner with enough context to investigate. Define the workflow for failed, repeated, or delayed exchanges.
- 04
Reconcile and document
Confirm what completed and what remains unresolved. Provide routine checks, operating instructions, and a traceable handoff for the agreed implementation.
Prepare for discovery
Bring the process and representative records.
The systems and exchange path
List the platforms, trading partners, supported connection methods, and the records that move between them.
Normal and difficult examples
Provide representative exchanges and known exceptions through an agreed secure channel. Include missing data, failed deliveries, and the current resolution process.
The evidence your team needs
Agree the acceptance checks, traceability, operating documentation, and ownership needed to use and maintain the selected implementation.
Implementation, end to end
A working process your team can operate.
01
Understand the current work
Walk through a real request with the people doing the job. Identify the source records, decisions, bottlenecks, and exceptions before choosing software.
02
Build a useful pilot
Define a limited starting scope and create a working version. Test representative requests alongside difficult cases, missing data, and failed connections.
03
Launch with clear ownership
Agree access, approval steps, acceptance checks, and a release plan. Show staff how to use the system, review exceptions, and contact the responsible owner.
04
Maintain and improve
Provide the agreed documentation and handoff. Review usage, operating costs, and issues; define support coverage and future changes in the engagement.
Before we begin
The questions that shape your project.
Bring the business problem. We can help translate it into a practical technical plan.
Can you work with our existing software?
We review the systems you use, available APIs or supported imports, subscription requirements, and access permissions. The scope identifies which connections can be implemented and which need an alternative.
What do you need from our team?
A process owner, examples of the current work, and access to the systems included in the scope. Your staff help confirm the business rules, review a pilot, and decide whether the result is ready to use.
How are cost and success agreed?
The proposal defines deliverables, assumptions, responsibilities, acceptance checks, and pricing. Third-party subscriptions and usage costs are identified separately. We choose meaningful measures from your existing process rather than promise an untested result.
What happens after launch?
The agreement defines code and account ownership, documentation, training, deployment responsibilities, and any ongoing support. Staff get a clear way to handle failures and requests for changes.
Regulatory reference: FDA Drug Supply Chain Security Act information
Let’s talk about what you want to improve.
A short conversation can help you decide where AI and better systems would make a useful difference.