How to Select the Best LIMS for your Lab: Part One
Selecting any type of product that's best for you has never been an easy process, whether it is a new dishwasher for your home or a new balance for your lab. What's best for you is wrong for someone else, and vice versa. There is no "best" solution, only the best solution for you. Yet even with due diligence, poor choices happen. The dishwasher stops cleaning dishes the day after the warranty expires or the balance, while inexpensive, causes workflow bottlenecks. Why is it so hard to get it right?
Often the problem starts with cost justifying and budgeting for the purchase. In the case of a LIMS or informatics project, the cost justification is just one aspect of selecting and implementing such a solution. Once a budget is set, selecting the appropriate solution should be a straightforward process. A list of requirements is created. Products are reviewed for appropriateness. A choice is made. Unfortunately the process of selecting a LIMS is often fraught with error, misunderstanding, and failure.
The budget has a lot to do with it. Your organization may not be able to afford what you need, and any solution that is implemented will be less than ideal and never popular.
Any LIMS or Informatics decision crosses departments, involving not only the lab but also the IT department. IT may have infrastructure requirements that don't address lab requirements. The decision becomes a team effort that can mean compromises.
In addition, the process is time-consuming. It takes time to define the requirements, time to research products and interview vendors, time to get the budget approved, and time to implement. Sometimes this can take two to three years. A lot of things can change in that time. A new lab manager may favor a different LIMS solution. IT may decide on a different corporate standard. A new Vice President may want a complete review of the project. The budget may be cut. The scope may expand. There are many areas where hurdles may arise. One statistic currently circulating is that some 60% of all LIMS projects never get implemented. Some of the blame rests with the vendor; but some of the blame rests with the organization purchasing the product.
What then is the best methodology for ensuring success?
Be aware that selecting a LIMS will not be an easy process. Follow a classic project management approach. Clearly define the scope, objectives, and resources available for the LIMS. "Scope creep" is one of the major reasons for failure to implement the LIMS on time or within budget. Define the functional requirements that the LIMS must address in order to perform the necessary laboratory tasks. Then review the available LIMS that fit your budget and requirements and interview those vendors.
It is important to remember that evaluation criteria must include not only functionality and total solution cost, but also ease of use and the degree of impact the LIMS will have on existing systems and technology. Companies often develop a requirements scorecard to define the relative importance and value of criteria such as batch log-in and assignment of default values for data capture.
Not every LIMS solution is the same; it is doubtful that all your requirements will be met by a single solution, therefore assigning a value to the functional requirements enables your organization to better assess how well a specific LIMS addresses your laboratory's processes.
Requirements Definition is Key
LIMS selection boils down to what you have, what you want, and what you need (knowing that you can't always have what you want). Start by creating a LIMS implementation team that includes an upper management champion (to ensure that your budget gets approved), the lab manager, LIMS users, Quality Assurance staff, and IT staff who can help steer your team through the IT infrastructure requirements that the LIMS will need to accommodate.
Once the team is formed, they develop the project plan and start the process for defining the Functional Requirements Specifications (FRS) for the LIMS. Pay close attention to the desired functions and features of the LIMS, including:
- Definition of plans and studies for manufacturing and testing of samples
- Sample log-in and tracking
- Work assignment and scheduling
- Connection to instruments and instrument computers
- Acquisition, calculation and checking of results
- Automatic limit/specification checking
- Test method and specification storage/retrieval
- Report approval and release
- Automatic report generation
- Lab productivity reporting and backlog reporting
- Billing and accounting functions
- Audit trails (GALP, GLP, GMP, ISO 9000)
- Connection to other information systems, such as process control systems, manufacturing systems, accounting systems
- And, data archiving and retrieval
Remember that it is essential to have a complete understanding of the data and information flow required by the laboratory. It's a good idea to create a diagram depicting the workflow of data and samples in the lab. Such a workflow includes log-in options, status tracking, data marking, audit trails, and other features vital to the lab.
Choosing a Configuration
LIMS selection is also difficult because it combines several technologies, including computer processors and storage, data acquisition and instrument control (e.g. interfaces and software), a database 'engine', a data communications network, procedural programming languages, data description languages, report writer software, and the system user interface.
There are high-end and low-end solutions and solutions in between. If the organization requires sophisticated relational database technology, some customization and hooking the LIMS into other business systems, then a client/server architecture is usually favored. If the organization only needs to implement the LIMS in the lab, a simpler web-based system is usually the LIMS of choice. Alternatively, in a multi-lab, multi-location scenario, the headquarters lab may implement a high-end client/server LIMS while smaller web-based LIMS are implemented in field offices that can then connect to the client/server architecture. Software-as-a-Solution (SaaS) LIMS take away the hardware headache and simplify the maintenance and location issues. The ultimate configuration can be almost anything. Determining what that configuration should be–and the appropriate LIMS products that should then be reviewed–is driven by the Functional Requirements Specification and the budget allocated for the project.
Next month, Technology Networks will present the second installment of this two-part article, which will examine processes associated with interviewing LIMS vendors, implementation and installation, as well as getting started on your cost justification.
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