Challenge: Serialization with No In-House Expertise
USDM's expertise with TraceLink ensured a successful implementation of the serialization system and a smooth transition for the company's Quality and IT teams with seasoned change management education.
Through scientific and clinical excellence, deep engagement with patient communities, and commercial expertise, the company is building its leadership in specialty pharmaceuticals for autoimmune disease to deliver long-term value to patients and the healthcare system. But the company faced an urgent gap: it had no serialization experience and no in-house expertise to implement TraceLink.
- Customer had no experience with a serialization product
- Customer needed to quickly implement a serialization system in order to provide therapies to patients waiting on their first dose
- They did not have the in-house expertise to implement the TraceLink system for serialization data access, verification, and reporting
- Customer needed GxP implementation expertise as well as organizational change management to drive system adoption
- Customer needed help managing the project and establishing roles and responsibilities to ensure on-time completion
Because serialization data underpins traceability and reporting, the work also had to stand up to data integrity and 21 CFR Part 11 expectations from day one.
Approach: Configure, Validate, and Drive Adoption
USDM led the implementation end to end — from system configuration and validation through change management — and applied a risk-based computer software assurance mindset to focus testing where it mattered most.
- USDM configured and implemented the TraceLink system, and helped the customer understand and maximize its functionality
- USDM optimized the system based on the customer's unique business needs
- USDM established roles and responsibilities for the various parties involved (third-party logistics, contract manufacturing organizations, etc.)
- USDM enabled messages to be sent from one system to another and confirmed with performance qualification (PQ)
- USDM educated the customer on configuration changes required in the production environment and executed them on time
- USDM guided the Quality and IT teams through change management and kept the project team on schedule and under budget
- USDM continues to manage the customer's compliance by handling TraceLink quarterly updates to maintain their validated state with Cloud Assurance
- USDM provided the customer with a defensible TraceLink Audit to minimize their validation efforts
- Successfully coordinated various parties to deliver project on time and under budget while ensuring adoption of new system
Coordinating Third Parties
With third-party logistics providers and contract manufacturing organizations all in the data flow, USDM also brought structure to third-party risk — clarifying roles, responsibilities, and system-to-system messaging so every party knew its part.
Results
- On-Time and Under Budget while ensuring TraceLink adoption
- Dramatically increased customer's knowledge of the system and its functionality
- Significantly reduced validation burden by leveraging USDM accelerators and vendor documentation
By pairing GxP implementation expertise with change management, USDM turned a team with no serialization experience into confident TraceLink operators — delivered on time, under budget, and kept in a continuously validated state through Cloud Assurance quarterly updates.