Situation

A tobacco manufacturer used a home-grown LIMS to manage their QC and R&D laboratory data.  They began assessing their system’s capabilities after the passage of the Tobacco Control Act (TCA) of 2009. This act requires tobacco manufacturers with more than 350 employees to adhere to GMP and maintain data regarding ingredients and packaging—the FDA could audit such manufacturers every two years.  As the assessment progressed, resources became an issue and the assessment team engaged CSols Inc. to complete the requirements definition and support selection of a new LIMS vendor.

Objectives

The client aimed to select and implement a LIMS to support TCA-compliant laboratory data generation and maintenance.  The client required a new system flexible and extensible enough to support current and future regulatory needs.

Challenges

  1. The client’s existing infrastructure was dated and related IT decisions were still pending during the CSols engagement.
  2. A parallel chromatography data system (CDS) selection project used overlapping client SMEs and other resources.
  3. The timeline for the selection project was aggressive.

CSols’s Role in the Solution

  • CSols experts leveraged the client’s existing needs assessment and requirements documents to
    • Perform business analysis of the manufacturing and laboratory processes
    • Support in-depth site tours and interactive workshops
    • Develop future state workflows for the in-scope laboratory areas.
  • From the future state workflows, CSols
    • Developed user requirements specifications (URS)
    • Developed the request for proposal (RFP)
  • In addition, CSols
    • 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
    • Recommended a path forward aligned with the client’s needs and industry best practices

Benefits

  • Revived the LIMS requirements gathering process and maintained the pace to complete the engagement on time and within budget.
  • Expanded upon existing client documents, reducing the project timeline and associated costs.
  • Accelerated LIMS vendor selection processes and fast-tracked the project.
  • Increased client’s confidence in LIMS ability to meet current regulations and adapt to regulatory changes.

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