The software design cycle usually begins with a User Requirements phase, which is used to generate the Functional Requirements of the system. These Functional Requirements are then used by the development team as a basis for the design and development of the system. Traditionally, these Functional Requirements are used to create a Project Plan which determines the timeline and amount of resources required to develop the system.

In LIMS projects, the Project Plan also contains the amount of time and resources that will be required to fully validate the developed system. The development team and the validation team work independently of each other in order to ensure that the developed system meets the agreed upon Functional Requirements.

During development it is not uncommon to uncover additional features that would enhance the system beyond the listed Functional Requirements. This discovery is the beginning of the slippery slope of scope creep. Scope creep usually begins with a member of the development team uttering the words similar to "Wouldn't it be cool if…." followed by the grandiose idea. This new feature may very well be a great addition to the product that is being developed or it may not, this is not important. The vital concern at this point is what is the cost of the addition? When the developer brings up the idea to the project manager it will usually be presented with the total development time requirement to add the feature to the product. There is usually no concern about the amount of additional time that will be required for system acceptance testing and validation.

The Functional Requirements should not be viewed as an unchangeable list of objectives. The natural course of a project will produce additions and exclusions to this list of objectives. However in order to avoid unnecessary delays in the project, it is vital for the design team to communicate any agree upon changes. to the list of the Functional Requirements, and to enlist the help of the validation team in determining the impact of any added features to the timeline and resource requirements to complete validation of the system. The ability for the project to remain on time and within budget will depend on the ability of the Project Manager to control Scope Creep.