Situation

A multinational biotechnology company used manual procedures and multiple applications, including LabWare LIMS, to manage laboratory data and processes.  Both the manual and automated procedures were labor-intensive and inefficient.  The lab team engaged CSols Inc. to assess workflow needs and software requirements as well as design optimized solutions. As part of the engagement, CSols also provided project management and validation services.

Objectives

The client wanted to streamline its laboratory processes as well as minimize its laboratory informatics footprint.  As part of these over-arching goals, the client aimed to retire redundant systems, lower IT costs, and increase data availability.  Specifically for their LabWare LIMS, the client wanted to maximize value by fully leveraging LIMS functionality.

Challenges

  • A large and diverse laboratory environment with numerous workflows to analyze and optimize
  • A large and diverse team, including client team members and vendor resources, needed to come to a consensus on existing processes and how to optimize workflows
  • Suboptimal communication among stakeholders due to the size and nature of the teams
  • Client project management and oversight resources were limited
  • The LIMS project required an interface with the selected BI tool, Qlik Sense®, but there were no client resources with the requisite Qlik Sense® expertise

CSols’s Role in the Solution

CSols provided business analysis, project management, documentation development, validation planning, and CSV execution resources to address these challenges.

  • Requirements analysis activities
    • Plate management requirements analysis
    • Barcode generation and printing requirements analysis
  • Documentation development activities for plate management and barcoding
    • User requirements specification (URS)
    • Functional requirements specification (FRS)
    • LabWare LIMS Plate Manager Module design specifications
    • Barcoding workflows design specifications
    • Barcode label design specifications
    • Validation documents for Qlik Sense® barcoding solution
    • Standard operating procedures (SOPs) for Qlik Sense® barcoding solution
    • Service level agreement (SLA) for Qlik Sense® barcoding solution
    • Test cases for Qlik Sense® barcoding solution
  • Implementation activities
    • Implemented barcoding solution for shipping and inventory workflows
    • Migrated sample inventory data from Freezerworks to LabWare LIMS
    • Implemented an automated sign-in solution for inventory transactions in LabWare LIMS
    • Sourced hardware for the automated sign-in solution
  • Validation activities
    • Developed Qlik Sense® expertise to support compliant system validation
    • Developed Qlik Sense® knowledgebase to support future client Qlik Sense® resources
    • Executed test cases for Qlik Sense® barcoding solution

Benefits

  • The implementation of the integrated barcoding solution
    • Eliminated paper for all shipping and receiving tasks
    • Improved inventory control and efficiency
    • Increased self-service for determining quantities and locations of samples
  • The optimization of laboratory processes and LabWare LIMS automation
    • Increased operational efficiency in the laboratory and the warehouse
    • Eliminated redundant applications like Freezerworks
    • Eliminated reliance on standalone spreadsheets and databases for laboratory work
    • Reduced IT costs related to redundant applications
    • Improved data quality
    • Minimized manual processes and related errors
  • The CSols validation documents and activities
    • Increased regulatory compliance
    • Increased audit preparedness
    • Maximized use of client’s internal resources during and after the project
  • The CSols project management activities
    • Increased process optimization consensus among stakeholders
    • Improved end-user buy-in and system adoption
    • Maximized use of client’s internal resources
    • Maximized project budget and schedule

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