CASE STUDY
Astrix Case Study – Seamless Onboarding of Simple & Complex Instruments
A revolutionary global biotherapeutics company focusing on gene therapy
Astrix Solution
- To effectively manage the complexities of the instrument onboarding program, a dedicated Project Manager was assigned to oversee all critical aspects of execution.
- Project Planning and Scheduling: Development, implementation, and maintenance of the overall project schedule to ensure timely delivery.
- Stakeholder and Vendor Coordination: Management of LIMS and instrument vendors to align deliverables and maintain quality standards.
- Project Management Best Practices: Application of PMI guidelines and industry best practices to drive consistency and efficiency across project activities.
- Risk and Issue Management: Proactive identification, escalation, and resolution of program risks, issues, and conflicts among all stakeholders.
Business Challenges Facing the Client
- Oversight and coordination of more than 1,300 GxP and non-GxP instruments, ranging from simple to complex systems.
- Adherence to stringent regulatory compliance and validation standards.
- Limited internal resources and bandwidth to meet an accelerated project timeline.
- Identified gaps in change management processes and employee training.
Results Delivered
- Developed and executed a comprehensive Instrument Onboarding Roadmap, enhancing transparency and stakeholder alignment throughout the instrument implementation lifecycle.
- Streamlined onboarding procedures by designing standardized project plan templates tailored to varying effort levels (Low/Medium/High) and compliance requirements (GxP/Non-GxP), resulting in increased operational efficiency.
- Created detailed training materials and successfully delivered remote “Train the Trainer” sessions, enabling scalable knowledge transfer across teams.
- Achieved significant reduction in instrument Go-Live timelines, accelerating time-to-value and improving overall project delivery.
