Situation

Rapid growth of a global biopharmaceutical had resulted in multiple instances of heavily customized LIMS, across many sites. Supporting these multiple customized instances and combining data presented a major challenge. Therefore, the client undertook a project to deploy a highly configured but less customized version of LabWare LIMS to all sites. The client chose CSols, Inc. to lead the LIMS deployment based on CSols’s demonstrated expertise on other lab informatics projects.

Objectives

The client wanted a single, core LIMS that was less customized and more configurable to fit the needs of all 5 sites, across three countries. The LabWare 6 LIMS was to be implemented in a manner that would also allow easier system upgrades, facilitate data sharing, and provide greater efficiencies for the future.

Challenges

  • Strictly limited client involvement: Work was to occur with minimal input from, and disruption to, client resources
  • Limited in-house bandwidth: The client’s staffing model used relatively few full-time employees and a substantial number of contractors
  • Aggressive timeline: The client also had a limited timeframe to complete the site deployments

CSols’s Role in the Solution

CSols was engaged to manage the site customizations/configurations and lead the multi-site rollout program. Below are the deliverables provided by each resource group from CSols.

  • Project Leadership Services
    • Project management to ensure that staff were prepared for system implementation
    • Created and maintained open communication lines between all sites
    • Coordinated scheduling of site rollouts, ensuring training was completed and site rollouts were properly coordinated and sequenced
    • Managed resources from multiple vendors, including the product vendor
    • Developed status reporting for senior level management
    • Appraised senior management of challenges requiring their attention
  • Development and Configuration Services
    • Added enhanced functionality to the core system (e.g., EM)
    • Performed development work for configuration and customization to fit site specific requirements
    • Site extensions to the core LIMS included the addition of an Environmental Monitoring (EM) module and interfaces to the Empower™ 3 Chromatography Data Software (CDS)
  • SOP writing
    • Wrote SOPs for the LabWare LIMS
  • Validation Support
    • Wrote test protocols and scripts for the client’s customized LabWare LIMS implementation, using accumulated expertise with the system
    • Wrote test scripts for the LabWare to Empower 3 interface
    • Updated the set of masters (URS, FRS, TM, RA, and DS) based on the revisional release protocols, in conjunction with approved change controls

Benefits

  • On-time deployment of core LabWare LIMS to all sites was achieved, and the client also benefited from the Project Leader’s strong communication and centralized support throughout their project.
  • The client’s IT Sponsor’s time was efficiently used because the CSols Project Leader took the detail work and only escalated significant issues to the IT Sponsor.
  • Seamless management of the multi-vendor team by the CSols Project Leader provided the IT sponsor with confidence that the project was being managed effectively.
  • Procedures, scripts, protocols, and change controls were developed by the CSols implementation experts.
  • CSols developers provided a more harmonized system for improved information sharing, increased efficiency, and reduced cost, with an available future upgrade path.

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