xLM Validates TraceLink Application for Veloxis Pharmaceuticals
Exploring eco-friendly manufacturing methods. Veloxis Pharmaceuticals needed to validate its TraceLink track-and-trace system, a critical solution for managing transplant therapy distribution. With multiple TraceLink applications to manage and limited internal resources, Veloxis partnered with xLM to implement a scalable, cost-effective validation solution that ensures compliance and operational efficiency.
Measurable Wins That Matter
More than 50%
6
95%
Zero downtime
The Challenge
Veloxis faced several pressing challenges:
- Complex System Landscape: Multiple TraceLink apps required precise, coordinated validation to meet regulatory requirements.
- Resource Limitations: Internal teams needed external expertise to manage validation without disrupting core operations.
- Frequent Updates: Regular TraceLink updates required a continuous validation process to stay compliant and audit-ready.
- Cost Pressures: Traditional validation methods were too time-consuming and expensive to maintain long-term.
Veloxis needed a flexible, automated approach to manage validations effectively while reducing cost and effort.
The Solution
xLM implemented a Continuous Intelligent Validation framework tailored for Veloxis’ TraceLink ecosystem, including SOM, SMM, SNX, and Product Track applications.
Key actions included:
- Delivered end-to-end managed validation services for Veloxis’ dedicated TraceLink environment.
- Provided seamless integration support for CMO (Contract Manufacturing Organizations) and 3PL (Third-Party Logistics) partners.
- Built a robust release management framework capable of handling up to six TraceLink releases annually.
- Created a delivery model requiring less than 5% of the typical validation effort, significantly cutting costs and timelines.
The Result
The collaboration with xLM delivered measurable success for Veloxis:
- 50%+ reduction in validation costs compared to traditional approaches.
- Smooth, successful go-live of Veloxis’ TraceLink implementation.
- Efficient, scalable validation processes requiring minimal internal team involvement.
- Continuous compliance readiness with ongoing validation for frequent TraceLink updates without added cost or strain.
Services Provided
- Software Validation
- Validation Planning
- Regulatory Compliance