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LIMS Software System Design and Validation

With industry-leading experience designing, configuring, validating, and/or deploying LIMS software solutions for our clients, we’ve had the amazing opportunity to impact the life-saving products and therapies our clients create and distribute every day – an opportunity we are continuously grateful for with each project.

This particular project was no different, each one of our LIMS consultants woke up daily knowing we were making a difference for our clients and their patients. At the heart of LIMS software, you’re watching out for product safety and efficacy. So as new members rolled on to the project, we made sure we drew the connection between the work we were doing and its impact to the medicines our families and loved ones take every day.

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Founded over 100 years ago, the client develops and produces medicines and vaccines for a wide range of medical disciplines, including immunology, oncology, cardiology, endocrinology, and neurology.

The drug maker faced significant challenges with their laboratory automation platforms, used to support and optimize ongoing laboratory operations.  Differing technology strategies and multiple mergers and acquisitions led to dynamic, site-specific business processes and laboratory information management systems (LIMS) configurations. Furthermore, the current LIMS software was approaching end-of-life status with the vendor.  As a result, the costs of maintenance, support, and compliance for their LIMS platforms were continuing to rise.

Clarkston Consulting collaborated with the client to achieve process harmonization, requirements definition, system configuration, and validation of a global LIMS software system, leading to one of the most advanced, integrated, and standardized laboratory automation and global quality data warehouse systems in the world.

LIMS Software System Design and Validation – Primary Objectives

  • Harmonized business processes, data structures, and best practices across sites
  • Improved operating efficiency utilizing standardized master data configurations and improving real-time data analytics
  • A foundation for future adaptation of paperless labs to reduce human error
  • Simplified and streamlined global LIMS IT landscape

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Tags: Quality and Compliance Technology, Services, Case Study
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