Situation

A world leader in in vitro diagnostics and biomarkers production sought to identify and implement an Electronic Lab Notebook (ELN) solution that could be integrated into its current informatics landscape.

Goals

The primary goal of this project was to select a new ELN that would support and enable the company’s growth by meeting its long-term business, technology, and regulatory needs. With the implementation of an ELN solution, the company sought to eliminate its paper notebooks, reduce the amount of paper used in its operations, and automate a number of its manual lab processes.

Additional goals of this project included document management optimization, data quality and integrity improvements, increased regulatory compliance, and improved user experience.

Challenges

  1. Lack of ELN knowledge: best practices for the use of laboratory informatics systems were not habitual
  2. Lack of internal ELN expertise and resources: demand for laboratory work was so high that few SMEs were available to assist with the ELN vendor selection and configuration efforts

CSols’s Role in the Solution

This effort included the following key tasks and deliverables:

  • Strategic ELN selection services
    • Conducted requirements gathering interviews and workshops
    • Developed optimized laboratory workflows with improvement recommendations for integrated ELN processes
    • Developed user requirements specifications (URS)
    • Developed requests for proposals (RFP) and managed quantitative vendor evaluations
    • Developed vendor demonstration scripts, managed vendor demos, and quantified vendor analysis
    • Developed strategic roadmap document with short and mid-term implementation recommendations
  • ELN implementation support services
    • Captured and documented experiment workflow processes
    • Aligned workflow documentation with vendor configuration needs
    • Developed a common experiment, generic template for use by all groups
    • Developed an experiment specific template
    • Developed ELN SOPs for administration, operation, and ELN controls
    • Developed an ELN good practices guide to support rollout of future functionality

Benefits

      • Increased flexibility to support constantly changing business needs
      • Improved quality and consistency of data sets leading to better decision making
      • Optimized workflows resulting in increased efficiency and productivity
      • Reduced dependency on paper records
      • Improved regulatory compliance
      • Increased efficiency via review process automation
      • Increased collaboration through the centralization of all data and information within the ELN

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