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Why System Requirements are an Essential Part of Your Informatics Project

Laboratory informatics projects can be extremely complex and costly. LIMS projects, for example, require large investments of money, resources and time – costing anywhere from hundreds of thousands to millions of dollars, while requiring hundreds to thousands of resource hours, to implement. Given the financial, regulatory and operational risk to your organization that a laboratory informatics project represents, it is imperative that you get the project right the first time.

One of the keys to a successful laboratory informatics project is the development of a comprehensive set of functional and technical requirements for the system in question. Properly developed requirements are critical to guide and inform many different aspects of a successful informatics project. Too often, companies fail to do the necessary work in this area and end up deploying a system that fails to realize the potential business benefits that served as motivation for the project in the first place.

Let’s explore some of the reasons why a comprehensive set of system requirements is so important for the success of your informatics project.

Benefits of Gathering System Requirements

The future state requirements gathering process helps to answer the following questions:

  • Why are we implementing this system?
  • What do we need this system to do?
  • What benefits do we expect to get from the implementation?
  • What changes can we make that increase productivity or enhance compliance?

Failure to develop system requirements for a software development project can lead to scope creep resulting in increased costs, longer duration, a need for extra resources, and ultimately a deployed system that does not live up to its promise of delivering business value for your organization. Surprisingly, many organizations still forgo a thorough requirements gathering process in their informatics projects despite the considerable capital investment required.

Best practice is to gather a comprehensive set of functional and technical requirements for your system and document them in a requirements document as the first order of business for the project team in your laboratory informatics project. Some of the benefits provided include:

Provides a Solid Project Foundation. The requirements document keeps your project on track by providing a solid foundation from which to work – developers know what to develop, and validation testers know what to test, and users know what to expect. Additionally, the project team can revisit the requirements document regularly to make sure the project stays on-track.

Ensures That the Project Generates Business Value for Your Organization. Properly gathered, comprehensive functional and technical system requirements align laboratory functional needs with the strategic needs of the business, serving to ensure that your deployed system will generate business value.

Guides Technology Selection. The requirements document allows the project team to have a clear picture of what the software solution must do before selecting a vendor. Without an optimized set of future state requirements, the project team has no effective basis to choose the best system for your organization. Companies often choose a system based on the flashiest demo or the system displaying the most bells and whistles. The ability to accurately capture optimized future state system requirements established by the project team is the only metric by which software applications and/or platforms should be judged.

Informs Architectural Decisions in the Laboratory. Best practice is to utilize the future state requirements for the system in question to design a future state architecture, along with a strategic roadmap to deployment that is aligned with business goals in terms of functional priorities and site sequencing. The ultimate result of this process is a practical roadmap to implement an overall strategic vision for the laboratory informatics architecture that will provide significant business value.

Provides a Basis for Testing. Given that the system requirements document desired functionality, they can be used as a basis to design the user acceptance testing (UAT) and form the fundamental underpinnings for computer system validation.

Facilitates User Adoption. A comprehensive requirement gathering process facilitates user adoption through effective communication and engagement with users. Users buy-in to the future state being implemented because they are consulted throughout the process and help to shape the future state workflows. This collaborative approach ensures that the implementation will address user needs and thereby helps to facilitate user adoption.


In order to create a successful strategic plan for your organization’s laboratory informatics project, requirements gathering should be done by a business analyst (BA) with appropriate domain knowledge (e.g., scientific background, industry knowledge, an understanding of the laboratory environment, IT knowledge, as well as expertise in the informatics system being implemented). This experience and knowledge are critical to be able to develop an optimized future state model for the laboratory. Using generic business analysts for a laboratory informatics project will inevitably result in missed opportunities for workflow optimization, ultimately reducing the value of the system implementation to your business. Additionally, while the requirements gathering process is led by a BA, it is important to involve all stakeholders in the process – project manager, users, developers, management, IT, testers, etc.

Astrix Technology Group is a full-service global laboratory informatics consulting, regulatory advisory and professional staffing firm focused on serving the scientific community since 1995. Our experienced professionals incorporate requirements gathering as part of a comprehensive methodology that serves to ensure the success of your laboratory informatics project. If you would like to discuss your system requirements or overall laboratory informatics strategy with one of our informatics experts, feel free to contact us for a free, no obligations consultation.