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Delivery of a Global, Harmonized LIMS System During COVID-19

Contributors: PK Sundar

After being engaged for a site deployment of the project, Clarkston was asked to take over the program as the new system integrator and replan the entire LIMS system project – a build out and deployment of global integrated end-to-end laboratory system to 5 sites across the world. After thorough planning, Clarkston presented a revised plan and approach, and demonstrated feasibility with a proof-of-concept system release. Clarkston approached the project by focusing on harmonized business processes as the foundation of the system and emphasized working with the client to set clear scope and deliver not just on user requirements, but on end-to-end processes.  Clarkston’s robust project management expertise ensured flawless delivery of releases and supplemented efforts with the team necessary to achieve project goals including business analysts, a site deployment team, and a training and change management expert. 

Download the full LIMS System Case Study here

Midway through the project, the team was faced with the challenges of COVID-19 which caused the entire initiative to pivot into a primarily remote delivery for the next year of the project until the end of the program. Through these complications and Clarkston’s management, the program was completed on budget, within timeline without significant reduction of scope.

At the onset of the project, Clarkston set out ojectives to:

  • Implement integrated end-to-end laboratory systems and processes within GMP development and commercial operations that will deliver compliance, efficiency, scalability and sustainability, and enable strategic analytic and lifecycle knowledge management capabilities
    • Demonstrated Clarkston’s flexibility by pivoting easily to 100% virtual delivery of services due to Covid-19.
  • Develop a harmonized lab system to support business operations that would drive operational improvement in a harmonized fashion
  • Develop and implement of lab systems master data strategy
  • Establish robust global lab system governance and change management
  • Considerations included interfaces, knowledge management and operational systems
  • A reduction of manual processes to mitigate data integrity and compliance risks
  • Scalable business processes and technology
  • Reduce customizations that hinder upgrades, flexibility and scalability by using out of the box functionality when possible

Download the full LIMS System Case Study here

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Tags: Case Study, Change Management, LIMS, Training, Program Management