Situation

A clinical-stage biopharmaceutical company needed to replace the LIMS in their GMP QC labs, which was reaching its end-of-life.  Management wanted to include their GLP bioanalytical services lab in the LIMS replacement project, as that area was using a patchwork of home-grown solutions to manage its workload.  Unsure if one solution would meet the needs of both organizations, the company turned to CSols Inc. to support their lab informatics solution selection.

Objectives

This project primarily aimed to identify a replacement for the soon-to-be-decommissioned LIMS that supported the GMP lab. In parallel to the LIMS selection, the GLP lab wanted to streamline and standardize its operations with a laboratory informatics system.  CSols’sfirst objective was to assess the needs of the GLP lab and understand if a single system could meet all the requirements for both labs.

Challenges

  1. The project timeline was tight due to the existing LIMS going off support.
  2. The client had limited internal resources with LIMS or ELN experience.
  3. The client had limited internal resources with IT project management experience.
  4. The needs of the GLP lab and the GMP QC lab were very different.
  5. Stakeholders in both of the labs had pre-existing opinions about which solution they needed.
  6. There was a strong bias toward using a single system for both labs.

CSols’s Role in the Solution

CSols provided lab informatics experts with broad knowledge of available lab informatics solutions as well as the techniques used in each lab.  Over the course of the project, these consultants:

  • Educated stakeholders about the available solutions for each lab
  • Performed requirements gathering and confirmed those requirements in a series of on-site workshops
  • Developed a user requirements specification (URS) that covered the needs of both labs
  • Managed the request for proposal (RFP) process
  • Assisted the client selection team with the quantification of RFP responses
  • Managed the vendor demo process
    • Developed vendor demonstration scripts
    • Assisted the client with the vendor demonstrations
    • Quantified the results for each vendor
  • Performed additional vendor analyses to compare costs vs. benefits for multiple scenarios

Benefits

  • CSols’s assistance clarified and documented the laboratory and business needs for each lab group
    • The client selected a product for the GMP lab that could be implemented and validated quickly
    • The client selected a different product for the GLP lab that would take longer to implement but could be configured exactly to their unique needs and remain GLP compliant
  • CSols’s guidance brought the multiple teams to a consensus on a path forward
  • The client leveraged CSols’s documentation to speed the vendor implementation process

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