Fragmented applications
Related labeling tasks were spread across systems with overlapping responsibilities.
Anonymous medical technology case study
Unifying medical-device labeling workflows for regulatory compliance
A global medical technology manufacturer needed to consolidate fragmented labeling systems and give its Asia-Pacific organization a clearer way to manage regulated product data.
The situation
Separate labeling applications made regulated product data difficult to coordinate.
Different teams relied on several aging .NET applications for label creation, product identifiers, approvals, and data exchange. The systems served important compliance processes but created duplicated effort and limited end-to-end visibility.
The client needed a centralized platform that supported FDA UDI requirements while remaining usable across manufacturing operations. Launch planning and stakeholder coordination were led through the client's Asia-Pacific HQ.
The challenge
Consolidate regulated workflows without weakening traceability or launch control.
Label content, identifiers, approvals, and exchanges had to remain accurate while teams moved away from separate legacy tools.
Regulatory traceability
UDI data, label versions, approvals, and exports required consistent validation and audit evidence.
Operational rollout
Manufacturing and regional stakeholders needed a controlled transition and responsive launch support.
The solution
A central labeling platform combined data consolidation with compliance-oriented workflow design.
The team first unified core records and exchanges, then added workflow improvements around approval, visibility, and operational use.
- 01
Consolidate the core
Bring label, identifier, and reference data into one governed application and data model.
- 02
Validate exchanges
Use EDI and integration processes to standardize regulated data movement and reduce manual handling.
- 03
Support adoption
Prepare users, monitor launch behavior, and resolve issues quickly through coordinated regional support.
How we worked
Separate core consolidation from enhancement and adoption.
The first phase focused on replacing overlapping system responsibilities with a reliable central product.
The next phase added practical workflow and visibility improvements informed by user feedback.
Launch support through the client's Asia-Pacific HQ connected delivery engineers with operational and compliance stakeholders.
01Inventory
Map labels, identifiers, approvals, and exchanges.
02Consolidate
Unify data and core workflows in one platform.
03Enhance
Improve validation, visibility, and user journeys.
04Launch
Coordinate rollout and responsive support.
The result
The manufacturer gained one governed workflow for labeling and UDI data.
The centralized platform reduced fragmentation, improved real-time visibility into regulated records, and gave teams a clearer basis for compliant labeling operations.
Centralized labelingacross previously separate applications
UDI-ready workflowfor validation, approval, and exchange
Regional launch supportcoordinated through the Asia-Pacific organization
Stronger traceability
Versions, validations, and approval states became easier to review in one place.
Less duplicated work
Shared data and workflows reduced repeated handling across separate tools.
A maintainable compliance base
The platform could absorb future labeling and integration changes more safely.
Case taxonomy
Searchable by industry, technology, product, and business need.
Industry and product
- Medical Technology
- Manufacturing
- Product Labeling
- Device Data
Technology and delivery
- .NET
- EDI
- SQL Server
- SSIS
- Phased Consolidation
Business need
- FDA UDI
- Regulatory Compliance
- System Consolidation
- Real-time Visibility
- Data Exchange
Unify regulated product workflows
Need to consolidate compliance-critical systems without losing traceability?
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