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Before labs implement new software, they should document everything the software needs to do. These “requirements” will ensure the software does what the lab intends. However, not all requirements are created equal. Different types serve different purposes throughout the software lifecycle.
If your lab is implementing a new software solution or extending an existing system — whether it’s a laboratory information management system (LIMS), laboratory information system (LIS), electronic lab notebook (ELN), chromatography data system (CDS), or other type of software — you’ll need to understand the different types of requirements and their specific uses.
Business requirements describe the lab’s high-level needs and objectives. They explain why the software is being implemented from a business standpoint and highlight the value to be delivered via outcomes. For example, labs might seek to improve turnaround time, regulatory compliance, or data integrity.
Labs generally define business requirements at the beginning of a software project to align stakeholder expectations and provide context for all subsequent requirements. Business requirements form the foundation for justifying the investment and setting the project scope.
In contrast, user requirements capture the needs of specific users or user roles within the lab. They describe what users need to do using the system to perform their jobs effectively. For example, “Technicians must be able to record test results directly from the bench,” and “Quality managers need access to audit trail reports.”
User requirements are usually documented during early-stage workshops, interviews, or surveys with end users such as technicians and quality managers.
Functional requirements specify what the software must do — the features and functions it must have to meet business and user needs. They are typically more technical and detailed than either business or user requirements and are written from the system’s perspective. For example, “The system must support barcode scanning for sample tracking” or “The application must support multi-step workflows for microbiology testing.”
Defined during system design and validation, functional requirements explain how to achieve outcomes and describe a solution to the problem to be solved. They guide development, configuration, and testing so the software works as expected.
Unlike functional requirements, non-functional requirements define how the system should perform rather than what it should do. They include quality attributes and product properties, such as scalability, security, usability, and regulatory considerations. They also define expected system performance. For example, “The system must be accessible 99.9% of the time.”
Non-functional requirements are developed throughout the project and are used during vendor evaluation, design, and performance testing. While important for compliance, system performance, and user satisfaction, non-functional requirements are critical for a lab’s long-term success, especially in regulated or high-throughput environments.
Configuration requirements describe how the software should be set up to fit the lab’s specific needs. These requirements reflect the customization and setup of system parameters and ensure the software reflects the lab’s terminology, processes, and data models. They are essential for ensuring the system aligns with lab physical workflows and standard operating procedures (SOPs). For example, “Configure a sample type called ‘Drinking Water’ with fields for pH, lead, and chlorine.”
Because configuration requirements tend to be more granular than other requirements, labs tend to document them during implementation and validation, often in collaboration with the software vendor.
While labs might be familiar with the previous types of requirements because they are commonly used for software projects managed utilizing various methodologies, they might be less familiar with user stories.
User stories are a special form of requirement used by software projects following the Agile methodology, an iterative process that focuses on continuous feedback and improvement. These requirements provide informal, user-focused descriptions of system features and tend to follow a simple format: “As a [user role], I want to [do something] so that [desired outcome].” For example, “A quality manager wants to export audit trails so that the lab is prepared for inspections.”
By keeping the focus on user value, user stories can help labs prioritize features during sprint planning and user acceptance testing. They’re more flexible than other types of requirements, which means they can support a lab’s changing business and software needs. However, their flexibility also means they tend to be high level. For this reason, they should always be used in conjunction with business requirements and further refined with more specific user and functional requirements.
While your lab might not need to document all these requirements for every project, understanding the different types will help your team prepare for a smooth software implementation.
Business requirements set the direction, user and functional requirements drive usability, non-functional requirements ensure performance, and configuration requirements tailor the system to your lab. Add user stories into the mix, and you have a complete toolkit for defining and implementing the best solution for your lab, whether you’re working with an in-house team or a software consultant.
Need help gathering or documenting your lab’s requirements? Reach out — we can help turn your needs into a roadmap for success.
