Over the years, we’ve been involved in a number of LIMS/ELN selection projects. In this new series of blog posts, we’ll take a look at some of the lessons learned from those projects.
One of the most common mistakes in an ELN/LIMS project is to assign arbitrary time-boxes for tasks. Timelines for assessments and implementation vary depending on the complexity of the scientific process that needs to be supported, the number of groups involved in the process, the number of instruments and assays, and the priorities involved. That said, the more time spent on an accurate assessment, the more smoothly the implementation usually proceeds.
Projects typically consist of two phases: Assessment and Implementation.
Assessment
The goal of the assessment phase is to understand your requirements, and how the available vendor-based solutions could help you address those requirements.
Requirements Gathering
During the requirements gathering stage, interviews are conducted with process owners.
- What is the critical path that your organization follows to get a product out the door?
- Who is responsible for each stage of the process?
- What data is generated and what technology is used to generate it?
- Where are the gaps in the process?
- What are the most time-consuming activities in the process?
- What kinds of activities span multiple processes? For example, sample management & inventory, batch registration, and protocol management.
Team members are interviewed about each stage in the process. Requirements elicited from these interviews are compiled and circulated to the working group for review and to senior leadership for approval.
The timeline for executing the requirements gathering stage varies depending on the size of the organization, the number of sites involved and the complexity of the process, and can take anywhere from 1-3 weeks.
Vendor Assessment
During the vendor assessment phase, requirements are compared to vendor capabilities to create a rank ordered list of vendors from which you can then downselect to the primary vendors that you want to interview. This can take 2-3 weeks depending on the number of vendors initially selected.
Downselection & Demos
After the downselection has occurred, requirements are sent to the vendors, and scoping discussions are held with each vendor to communicate your needs, and to setup demo schedules. At this point you should be looking at no more than 3 vendors.
The working groups, composed of members of your scientific teams, will review each of the solution demos. It’s best to record the demos so that you can review the solution, or so that members who weren’t available during the demo period can provide their input.
A master list of follow-up questions is prepared based on the input from each of the teams and circulated back to the vendors. This may lead to a second round of demos to help address specific questions.
The assessments of each of the team members is compiled to create an overall solution assessment and each solution is then given a weighted score. These are assembled into vendor score cards which can be reviewed by the senior leadership to make the final selection.
It may be possible to have a proof-of-concept system stood up, that your scientific team can then evaluate over the course of a week.
Implementation
The implementation phase is a partnership between the vendor and customer. During this phase the following types of activities will take place:
Vendor
- Stand up the production and test environments.
- Configure the system to support your processes.
- Configure the system to load and parse the high-priority assay data files.
- Configure reports, dashboards, and data analysis tools for the assays you’ll be running.
- Train staff who will be implementing the first round of assays.
- Test or validate the system. Depending on your regulatory needs, the system will either be tested with your staff present, or an in-depth validation performed. The testing may involve performance testing in addition to verifying that the system meets the functional requirements.
Customer
- Identify and gather the data files that must be used for the initial implementation of the high priority assays.
- Training
- Provide acceptance test/validation feedback
- Provide configuration feedback.
Read more of the ELN/LIMS Blog Post Series
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