A Functional Requirements Specification (FRS) is necessary for a computer system validation as it will be used to describe what the system’s intended capabilities will be and how it will interact with other systems or instruments. A thorough FRS is needed to ensure that you have validated all functions related to the intended use. 

This customizable template provides space for all of the relevant requirements, with examples and suggested references.  

Template sections include:

  • Introduction (system description, document purpose, scope, definitions and acronyms, functional requirements objective)
  • System Functions (Instructions on how to record requirements, example requirement topics around system performance, safety and security, and configurable functions)
  • Data Functions (Example requirement topics around system access, data integrity, data capacity, and data archiving)
  • Interface Requirements (example requirement topics when considering what your system interacts with)
  • Reference Document Table


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    • Functional Requirements Specification (FRS)

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