What does my lab’s “requirements” mean?

When a laboratory information management system (LIMS) vendor asks you about your lab’s requirements, they seek a clear understanding of what your laboratory needs and expects from their software solution. The list of these requirements is often called a User Requirements Specification, or URS. By providing a comprehensive list of your lab’s requirements, you enable the LIMS vendor to propose a solution that aligns with your needs and helps you decide which LIMS system best suits your laboratory’s operations. It’s essential to be as specific and detailed as possible to ensure a successful implementation that meets your expectations.

Types of requirements you should consider

Below are example requirements you should discuss with a LIMS vendor. Although there are many similarities in requirements among labs in a given industry, every lab is unique. It’s essential to be thorough and detailed. LIMS software requirements should be documented, prioritized, and used as a basis for vendor selection and system customization. Involving key stakeholders from your lab in the requirements-gathering process ensures that you consider all relevant perspectives.

Budget and cost requirements

Clearly define your budget limitations, including licensing, implementation, and ongoing maintenance expenses.

Timeline and implementation requirements

Project timeline– Outline your preferred timeline, including milestones and go-live dates.

Implementation approach– Indicate whether you prefer a phased rollout or a full-scale implementation.

Functional requirements

Sample management– Define how you want samples tracked, labeled, and organized within the system.

Workflow management– Specify your lab’s workflow processes, including sample accessioning, testing, and reporting.

Data entry and capture– Describe the data fields and formats needed for sample and test data entry.

Instrument integration– Detail the types of laboratory instruments that require integration and their data formats.

Data analysis and reporting– Outline the required analytical methods and reporting formats.

Quality control (QC)– Define QC checks and validation criteria to ensure data accuracy and compliance.

Audit trails– Specify the level of data traceability and audit trail capabilities required for regulatory compliance.

Data management requirements

Data storage– Specify the storage capacity needed and whether it should be on-premises or cloud-based.

Data security– Describe data encryption, access controls, and user authentication requirements to protect sensitive information.

Data backup and recovery– Define backup frequency, retention policies, and disaster recovery procedures.

Data archiving– Specify long-term archiving requirements, especially if you need to retain data for compliance.

Integration requirements

Instrument integration– List the laboratory instruments, sensors, and equipment that must require integration with the LIMS.

**Third-party software- Identify other software systems (ex., ERP, CRM) that must be connected for seamless data sharing.

Compliance and regulatory requirements

Regulatory standards– Specify the regulatory standards (ex., FDA, CLIA, ISO) your lab must adhere to.

Compliance features– Detail compliance features your lab requires, such as electronic signatures, version control, and audit trails.

Scalability and performance requirements

Scalability– Describe how the LIMS should scale as your lab grows in terms of data volume, users, and testing capacity.

Performance– Define expected response times and system performance benchmarks.

User requirements

User roles– Identify roles (ex., lab technicians, administrators) and their respective permissions.

User interface preferences– Specify user interface preferences, accessibility requirements, or mobile device compatibility needs.

Support and maintenance requirements

Technical support– Specify the level of technical support required, including response times and support hours.

Software updates– Clarify your expectations regarding software updates, patches, and bug fixes.

Training and documentation requirements

Training needs– Identify the training requirements for different user groups and the preferred training methods, on-site or online.

Documentation– Inquire about the availability of user manuals, training materials, and documentation for troubleshooting.

Data migration and legacy system integration requirements

Describe any data migration needs from existing systems or spreadsheets into the new LIMS and specify requirements for integrating historical data from legacy systems.

Regulatory reporting requirements

If your lab generates regulatory reports, specify the formats and content required for compliance.

Data analysis and visualization requirements

Define any specific data analysis, visualization, or dashboard requirements for management and decision-making.

Solution-based URS

It’s important to remember that your lab is seeking a LIMS or LIS in the first place to solve problems and address pain points. Ensure your URS includes the items to make the successful system a solution.

Remembering that a LIMS solution is a significant investment, just like any key instrument, is also essential. For it to justify that outlay, it must provide returns in the form of time and effort savings, reduced errors, increased productivity, shorter turnaround time (TAT), and ease of use. But equally important is its ability to grow and change with your lab so that it does not become a bottleneck due to inflexibility. If any and every modification will be a painful wait for developer work – or worse, if the vendor does not provide comprehensive support – you may be continuing to spend large amounts while experiencing ongoing new pain points.