Situation

A generic and branded pharmaceutical manufacturer planned to transition away from paper record-keeping and a very old legacy LIMS, used for sample tracking only. In addition to manufacturing their own products, the client provides rapid contract testing and long-term stability testing for other pharmaceutical companies.

The new LIMS is needed to accommodate the rapid growth that the client has experienced, support their quality operations, and position the client for long-term growth. Due to internal resource constraints, the client chose to work with CSols based on our expertise in helping companies select the best LIMS product for their business. The client needed to follow a rigorous, well-defined process to ensure the selection of the most appropriate LIMS for their labs and workflows.

CSols was known to the client as a company that could take on and drive the client's unbiased selection of the right LIMS product for their business. CSols Inc. was selected to perform a strategic laboratory information management system (LIMS) selection and was also tasked with writing supporting documentation, such as a strategic roadmap outlining the deployment approach and timing for the selected LabVantage LIMS. The client chose CSols to meet the objectives defined for selecting a LIMS that will operate in a U.S. Food and Drug Administration (FDA)-regulated industry.

Objectives and Challenges

The client's goal was to create efficiencies and improve productivity in the contract testing and stability areas of their business. Without a LIMS, the client would continue to produce an unmanageable quantity of paper records, which have been inefficient and prevented the growth of the business. The tracking, traceability, and audit trail documentation of the data would continue to be difficult for quality management.

A clearly defined selection process was needed to help the client select the most appropriate LIMS for their needs. Companies without a process for LIMS selection can be swayed by sales presentations, which may not give them the best fit for their business. To achieve these objectives, there were a few hurdles to overcome as follows:

• All presentations were conducted remotely, due to the COVID-19 pandemic, and were recorded for internal review and for their out-of-scope Australia site.  
• The client had little experience with a LIMS, as they were using their existing system for sample tracking only, and needed to be educated by CSols about the increased functionality of modern LIMS products along the way.
• The client has a large backlog, so it was difficult to get the main stakeholders scheduled for certain tasks.

CSols' Role in the Selection

The goal of this project was to lead the strategic selection process and help the client select a LIMS based on an impartial data collection method. CSols developed a request for proposal (RFP) that was sent to seven vendors. The vendors answered questions as to whether their product could meet a series of well-defined requirements.

CSols reviewed each of the vendor responses, giving each answer weighted scores so the selection could be narrowed down to four. Each of the four selected vendors was invited to present their product to the client. The vendors all followed the same scripted demonstration, and the responses were scored by both CSols and the client's SMEs. The selection of LabVantage LIMS 8 was based on the results of the vendor demonstrations that CSols developed, which followed written scripts based on the client's business model.

Starting from the initial kickoff meeting, CSols consultants helped by setting up the project framework and developing deliverables as follows:

• Kickoff meeting oversight
• Staff interviews
• RFP development
• RFP scoring
• Demonstration script
• Oversight of vendor demonstrations
• Demonstration scoring
• Conclusion presentation describing which LIMS scored the best based upon the client's requirements
• Oversight of selection by the client
• Strategic roadmap development

Benefits

The selection process was conducted with rigorous standards and a well-defined process created by CSols, thereby allowing the client to select the most appropriate LIMS for their labs and workflows. In addition, CSols provided guidance and expertise as partners with the client throughout the selection process. The benefits the client received by following the proven CSols framework are as follows:

• The client can move away from legacy and paper systems to create efficiencies and growth with the choice of their LIMS.

• The effective CSols project leadership provided guidance for the successful completion of the strategic selection project.
• Well-defined deliverables (scripts, data presentations) were provided on time and within budget so that the client could make an educated LIMS choice.
• The client was able to make an informed decision based on feedback from CSols consultants based on real-world expert experience.
• The vendors successfully executed the easy-to-follow demonstration scripts that were provided by CSols.

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