NDC12 Readiness & Execution
Assess your readiness, build the right plan, and execute NDC12 across the systems, data, labeling, and teams that matter.
A simple format change with enterprise-wide impact
The FDA is moving to a uniform 12-digit NDC format. The change reaches far beyond labeling, affecting master data, IT systems, serialization, packaging, partner integrations, and commercial processes.
SCW helps you identify the gaps, prioritize the work, and manage the transition as one coordinated program.
Four areas to get right
NDC12 touches the core systems and processes that keep product, data, and operations aligned.
Data & IT
Master data, databases, interfaces, APIs, validation rules, reports, and downstream system logic.
Labeling & Packaging
Artwork, barcodes, packaging materials, print controls, serialization, and line readiness.
Partners & Supply Chain
CMOs, CPOs, 3PLs, distributors, wholesalers, and other trading partners that exchange NDC data.
Governance & Change
Regulatory, quality, commercial, finance, training, testing, ownership, and transition planning.
One structured path from readiness to execution
Use SCW for a focused workstream or for the full NDC12 program.
Establish your real NDC12 exposure before defining the solution
Find the gaps across systems, data, labels, partners, processes, and ownership.
NDC12 Readiness Assessment
Quickly identify readiness gaps and high-risk areas.
NDC Dependency & Touchpoint Inventory
Map where NDC appears across systems, data, labels, reports, and partner exchanges.
Risk & Criticality Assessment
Prioritize remediation by compliance impact, complexity, lead time, and business risk.
Stakeholder & Ownership Map
Clarify who owns each workstream, decision, and dependency.
Convert the impact assessment into one executable enterprise roadmap
Turn the findings into a sequenced roadmap with clear ownership and priorities.
Integrated NDC12 Roadmap
Build the workstreams, milestones, dependencies, and implementation waves.
Program Governance & PMO
Create clear decision rights, reporting, risk management, and executive visibility.
Budget, Resource & Vendor Planning
Define internal effort, external support, and resource needs.
Transition & Coexistence Strategy
Plan how 10-, 11-, and 12-digit representations will be managed where relevant.
Define the future-state rules before teams start changing systems
Define the future-state rules for data, systems, labeling, barcodes, and partner exchange.
Master Data & Mapping Design
Set ownership, field standards, mapping logic, and data-quality controls.
System Remediation Blueprint
Translate NDC12 gaps into concrete requirements for affected applications and interfaces.
Labeling, Barcode & Packaging Strategy
Align artwork, barcode, packaging, serialization, and line requirements.
Partner & Vendor Readiness Model
Define partner expectations, testing, and readiness tracking.
Coordinate remediation across functions without losing control of dependencies
Coordinate remediation across teams, systems, vendors, and partners.
Cross-Functional Program Execution
Manage dependencies, risks, decisions, and progress across workstreams.
System, Interface & Data Remediation
Coordinate implementation across applications, interfaces, and data flows.
Label, Packaging & Serialization Execution
Manage artwork, packaging, barcode, serialization, and line changes.
Trading-Partner Coordination
Track partner testing, issues, accepted formats, and cutover readiness.
Prove readiness, manage cutover, and stabilize the new operating model
Validate readiness, manage cutover, and stabilize the new operating model.
End-to-End Testing & Validation Coordination
Validate systems, data, labels, scanning, integrations, and partner exchange.
Cutover & Business Continuity Planning
Prepare transition, rollback, support, and supply-continuity plans.
Training & Change Management
Equip teams with the right SOPs, guidance, and role-based training.
Hypercare & Readiness Monitoring
Track defects, exceptions, and operational issues through stabilization.
March 7, 2033 is the effective date. The work starts much earlier.
System changes, labeling, testing, partner coordination, and validation all have different lead times. The earlier the dependencies are mapped, the easier the transition is to control.
Choose your next step
Start with the assessment, explore the white paper, or speak directly with our team.
How ready is your organization for NDC12?
Get a quick view of where your organization is ready and where the biggest gaps may be.
Start the AssessmentNDC12 Planning & Execution: From Regulatory Requirement to Enterprise Program
See how to structure NDC12 planning, governance, dependencies, and execution across the business.
Read the White PaperWhy SCW for NDC12
We combine pharma serialization, master data, program management, partner integration, and execution experience in one team.
Ready to move NDC12 forward?
Start with the readiness assessment or speak with SCW about your NDC12 program.
